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�h�h�hg�ynynynyn�5�=�'�=����������Title: 
Development of immunity in first year of life and call for vaccination.
Sameer Parekh and Sunil Shewale

Affiliated to: 
1. Sameer Parekh*, Manager: Clinical Trials at Serum Institute of India Ltd.; Pune. (India)
2. Sunil Shewale, Ex. Officer: Clinical Trials at Serum Institute of India Ltd.; Pune. (India) 

*Corresponding Author:
Name: Sameer Parekh 
Designation: Manager Clinical Trials 
Address: Serum Institute of India Ltd.
212/2, Off Soli Poonawalla Road,
Pune-411028; Maharashtra (India)
E-mail:  HYPERLINK "mailto:parekhsameer@gmail.com" parekhsameer@gmail.com 
Telephone: +91-92267-22745















Abstract: 
Children represent special needs because of their vulnerabilities and developmental peculiarities. The world cannot stand by while a child does not get a simple intervention that can save his/her life. Early protection is critical in children and the immunization in the first year is especially important. Hence to protect the child against some of the most dangerous diseases during and beyond the first year of life, it is essential that infants get all recommended vaccines at the right time. The vaccines work by building up the child's defenses against diseases. Some vaccines require multiple doses for full protection and every child must complete it.  HYPERLINK "http://www.factsforlifeglobal.org/06/2.html" A child who is not immunized is more likely to become sick, permanently disabled or undernourished, and could possibly die. This article explores the knowledge about importance of immunity before and after the beginning of human life and essential vaccines for children in the first year of life. 

Keywords: Immunity, infants, infectious diseases, vaccine, immunization

















Introduction 
Two million lives are saved each year through immunization. However, one-fifth of the world�s children about; 19.3 million children still go without basic immunization and millions of children died (Figure 1) from�vaccine-preventable diseases [1].  Immunizing children against vaccine-preventable diseases is an important factor in saving lives, increasing productivity, and alleviating poverty. Thus, infant child is scheduled to receive more vaccines during the first twelve months than any other time in his life. This busy schedule is necessary because the first twelve months is a very special time in child's life. A child's immature immune system isn't capable of fighting off serious and potentially fatal diseases such as  HYPERLINK "http://www.babycenter.com/0_measles_1417820.bc" measles and  HYPERLINK "http://www.babycenter.com/0_meningitis_1768.bc" meningitis. That's why Children need to be vaccinated in order to protect them from certain infectious diseases [2]. While, WHO and its Member States has also recognized this more than three decades ago when they chose six diseases; tuberculosis, diphtheria, neonatal tetanus, whooping cough, poliomyelitis and measles, as the targets for an initiative called the Expanded Programme on Immunization (EPI). 

Recommendations for immunization practices not only based on scientific knowledge of vaccine characteristics but also biology of immunization, epidemiology of specific diseases, and host characteristics. In addition, experience and judgment of public health officials and specialists in clinical and preventive medicine play a key role in developing recommendations that maximize benefits and minimize risks and costs associated with immunization. Consequently, general guidelines for immunization practices are based on evidence and expert opinion about vaccinations considering current epidemiology of disease. There may be minor variations in vaccination schedule between various medical offices. Since there is a window of time when the baby is recommended to receive many of the vaccines, each medical practice may tailor the immunization schedule to fit into the flow of the practice.




Transferable maternal immune protection and immune memory
While development of the immune system begins very early in fetal life exposure to antigen doesn�t occur until after birth. The period shortly before and after birth may be the key to understanding immunologic memory [3]. During this phase of development the immune system is relatively incompetent. For this reason, transferable maternal immunologic memory is essential for the survival of the fetus, newborn, and infant. Additionally, the attenuation of infection by transferable maternal immunity permits microbial agents to immunize the child under optimal conditions. Moreover, recent study shows that, the immune system of a pregnant mother stimulates cells that selectively prevent attack and rejection of fetal tissues recognized as being foreign which protect the fetus [4]. This key function of transferred maternal antibodies is also essential for the survival of birds and fish [5,6]. 

With exposure to pathogenic antigen the infant needs to develop a memory response too. This exposure to microbial antigen can occur in two ways a) from infection, or b) from vaccination. The exposure serves to educate the immune system about those infections and form immune memory. This means that when the infant is infected with the pathogen again, it will have a faster immune response and quickly neutralize them before they cause disease, or ameliorate the severity of the infection [7]. 

Development of immunity after birth
The infants� immune system is intact but immature at birth.� Some vaccines such as BCG and Hepatitis B work well when they are administered at birth whereas others do not generate as strong a response. The main problem with babies� immunity is that it is very na�ve.� At the time of birth babies have not been exposed to any pathogens.� Pathogen causes disease and it comes with its own set of peculiarities (Table 1). This means that babies have to generate a full immune response to every pathogen they encounter. Mucosal immune responses occur rapidly in the first weeks of life and its maturation and establishment of protective immunity varies between individuals but is usually fully developed in the first year of life, irrespective of gestational age at birth [8]. In addition, specific IgG antibody passes from the mother through the placenta to the developing fetus for the protection of the infant during the first few months of life. Passive transient protection by IgA against many common illnesses is also provided to the infant in breast milk.�Breast milk has also been shown to assist in the development of the infant�s own immune system. 

Meanwhile, the maternal antibodies decreased over the period of time, and young children, have underdeveloped immune systems, with much slower rate of antibodies production than adults. Thus, several vaccines are given to babies to help protect them against illnesses in early years of life. There is also some, although weak, evidence to show that breastfed infants respond better to some vaccines.�The major impetus however, for the expansion of lymphocytes (B and T cells) is the exposure to microbes which colonies the gut during birth. 

Essential vaccines:
The concept of essential drugs was developed in 1977 to guide WHO Member States as to the pharmaceutical products "that satisfy the health care needs of the majority of the population [9,10].  Now days, beginning in infancy, a child will receive a series of immunizations which are designed to protect against disabling and infectious diseases.� Immunizing children is hands down one of the most important and cost-effective public health interventions to ever happen.� Over the past two decades alone, more than 20 million lives have been saved and countless other children have been protected from illness, disability and death by vaccine. 

The nature of such vaccines exerts a direct influence on the type of immune effectors that are predominantly elicited and mediate protective efficacy (Table 2). Examples of such vaccines include those recommended for use in routine childhood immunization programmes; Bacille Calmette-Gu�rin (BCG) against tuberculosis, diphtheria-tetanus- pertussis (DTP), oral poliovaccine (OPV), tetanus toxoid (TT), measles, hepatitis B, and, where disease epidemiology supports them, yellow fever and Haemophilus influenzae type b (Hib) etc. A second category includes vaccines covered by WHO recommendations in accord with national priorities; for example, Japanese encephalitis B, vaccines, rabies or rubella vaccines [11-13].

Diphtheria Immunity 
Diphtheria vaccines are based on diphtheria toxoid, a modified bacterial toxin that induces protective antitoxin. The WHO recommendation for primary immunization of infants is to administer three doses of Diphtheria containing vaccine, starting as early as six weeks of age and given at least four weeks apart. Immunity against diphtheria is antibody-mediated. Because the lethality of diphtheria is almost entirely due to diphtheria toxin, immunity to diphtheria depends primarily on antibody against the toxin. Diphtheria antitoxin may be induced by toxin produced by Corynebacterium diphtheriae during the disease or the carrier state, or by diphtheria toxoid following immunization. Antitoxin is distributed throughout the body whereas circulating antitoxin levels below 0.01 IU/mL are non-protective, antibody concentrations of 0.01 IU/mL may provide some protection; levels of 0.1 IU/mL or more are considered fully protective. Antibody levels of 1.0 IU/ mL or more are associated with long-term protective immunity [14]. Cell-mediated immune responses to toxoid also occur and may be related to sustaining immunologic memory [14]. 

There is an age-related host response to immunization with diphtheria toxoid. The most important factor is the modifying effect of passively-acquired maternal antibodies in young infants. Early studies demonstrated that infants without maternal antibodies respond to diphtheria toxoid almost as well as older children [15]. The antibody level starts to increase after the second dose of DPT vaccine, and the level is considerably higher after the third dose. After the primary series, 94%�100% of children have antibody levels higher than 0.01 IU/mL. WHO has recommended addition childhood boosters at 12�24 months of age and at school entry. 

Measles Immunity 
Measles vaccines contains live attenuated measles virus propagated on human diploid cells. It induces humoral and cellular immune responses similar to natural measles virus infection. Antibodies first appear between 12 and 15 days after vaccination and typically peak at 21 to 28 days. IgM antibodies appear transiently in blood, IgA antibodies are predominant in mucosal secretions, and IgG antibodies persist in blood for years. Vaccination also induces measles virus-specific CD4+ and CD8+ T-lymphocytes [16, 17].  The proportion of children who develop protective antibody levels following measles vaccination depends on the presence of inhibitory maternal antibodies and the immunologic maturity of the vaccine recipient, as well as the dose and strain of vaccine virus. Frequently cited figures are that approximately 82%-95% of children develop protective antibody levels when given one dose of measles vaccine at 8-9 months of age. These figures are lower than sero-conversion rates and vaccine effectiveness estimates found in countries where measles immunization can be delayed until all children have lost maternal antibody (i.e. after 11-12 months of age), at which time sero-conversion rates as high as 93-100% may be achieved [18]. 

The immunological basis for providing a second opportunity for measles vaccination is to immunize those children who fail to respond to the first dose, as well as to vaccinate those who never received a dose. Those with poor immune responses to initial vaccination usually have a characteristic primary immune response, with production of IgM antibodies followed by high levels of IgG antibodies.

Tetanus Immunity 
Tetanus vaccines are based on tetanus toxoid. Conventional production includes growth of toxigenic strains of Clostridium tetani in a liquid medium that favours toxin production, toxin harvest by filtration, detoxification by formaldehyde and several steps of purification and sterilization. To increase immunogenicity, the toxoid is adsorbed to aluminium or calcium salts. Immunity to tetanus is antibody-mediated and depends upon the ability of antitoxins to neutralize tetanospasmin. Recovery from clinical tetanus does not result in protection against the disease in the future; immunity can be obtained by active or passive immunization only. Maternal tetanus antitoxin passes via the placenta to the fetus. Hence, when pregnant women receive a booster dose or the second dose both mother and child are protected against birth-associated tetanus. After one month, about 80% of antitoxin transferred from the mother is still present in the circulation of the newborn. The human placenta regulates the transfer of antibodies from mother to fetus in a selective manner such as transplacental transfer is restricted to IgG immunoglobulin. Fetal IgG antibody levels rise progressively from the fourth month of pregnancy until term. 

The minimum amount of circulating antitoxin that in most cases ensures immunity to tetanus is assay-specific. It has often been accepted that the minimum level of antibody required for protection is 0.01 IU/mL measured by an in vivo neutralization assay [19]. At birth, the infant usually has a total tetanus antibody concentration equal to, or sometimes higher than, the mother. Early studies found that the tetanus antitoxin levels in cord serum and maternal serum were usually equal, although in 20% to 30% of cases the cord serum had a lower titer than the maternal serum [19]. Both the efficacy and the effectiveness of tetanus toxoid are well documented. In most clinical trials, efficacy has ranged from 80% to 100%. A similarly significant reduction of neonatal tetanus mortality following the introduction of large-scale tetanus vaccination has been observed in numerous other countries [20]. The antibody concentration and avidity and also the duration of protection depend on a number of factors, including the age of the vaccinees and the number of and intervals between vaccine doses. Three doses in infancy will give 3�5 years� protection, a further dose or booster (e.g. in early childhood) will provide protection into adolescence, and 1 or 2 more booster(s) will induce immunity well through adulthood � duration of 20�30 years has been suggested.

Pertussis Immunity
Whole cell Pertussis (wP) vaccine is suspension of bacteria Bordetella pertussis that has been inactivated usually by formalin. The immune response to whole cell pertussis (wP) vaccines is directed against an array of antigens of whole bacterial cells. The pooled efficacy of wP vaccine against pertussis in children receiving three doses of primary series was raged from 61 to 89%. Newborns acquire antibodies passively from their mothers. IgG antibodies against FHA, PT, AGG2 and AGG3 have been detected in cord serum, or in serum from healthy children. Although there is placental passage of pertussis antibodies, most infants do not seem to be protected against clinical disease during the first months of life. The susceptibility of young infants to life-threatening pertussis has been well documented, with a high incidence of pertussis in the first six months of life. 

The latest version of the pertussis vaccine was released in the fall of 1996. This vaccine is called the "acellular" pertussis vaccine (aP). The new pertussis vaccine takes advantage of advances in protein chemistry and protein purification. The efficacies of aP and wP vary depending upon the case definition of pertussis used. However, the best aP vaccines have higher efficacy than low-efficacy wP vaccines but they may be less efficacious than the highest-efficacy wP vaccines in preventing whooping cough [21]. Recent study shows that, protection against whooping cough starts to weaken a few years after preschool children get their final diphtheria, tetanus and acellular pertussis (DTaP) shot because it might provide less-complete or shorter-lasting protection [22]. In order to maintain protection against pertussis throughout life, infant immunization schedules are being extended in many countries to include pre-school boosters, and also vaccination of adolescents and adults.

Poliomyelitis Immunity 
Two polio  HYPERLINK "http://en.wikipedia.org/wiki/Vaccine" \o "Vaccine" vaccines are used throughout the world to combat  HYPERLINK "http://en.wikipedia.org/wiki/Poliomyelitis" \o "Poliomyelitis" poliomyelitis (polio). The first is as Polio Salk, it consists of an injected dose of inactivated (dead)  HYPERLINK "http://en.wikipedia.org/wiki/Poliovirus" \o "Poliovirus" poliovirus. Oral Polio Vaccine (OPV); Polio Sabin is composed of live, attenuated polioviruses derived by passage of their parent WPV strains in nonhuman cells to give the 3 vaccine strains [Sabin 1 : type 1, Sabin 2: type 2, and Sabin 3: type 3) [23]. Passive immunity is transferred from mother to fetus via the placenta and the concentration of type 1 and type 2 IgG neutralizing antibody in the newborn is approximately equal to that of the mother. Type 3 titers are somewhat lower than those of the mother, suggesting differential transplacental transfer of this serotype. The rate of decay of maternal antibody is constant; its half-life is estimated at about 30 days (range 21 to 50 days) and these data have been confirmed in recent studies in developing countries [24]. 

Oral Polio Vaccine (OPV) alone, including a birth dose (known as zero dose because it does not count towards the primary series), is recommended in all polio-endemic countries and in countries at high risk for importation and subsequent spread. The primary series of 3 OPV or IPV (Injectable Polio Vaccine) vaccinations should be administered according to the schedules of national immunization programmes, for example at 6-10 -14 weeks, or at 2-4-6 months. 

Bacille Calmette�Gu�rin (BCG) Immunity
BCG is a  HYPERLINK "http://en.wikipedia.org/wiki/Vaccine" \o "Vaccine" vaccine against  HYPERLINK "http://en.wikipedia.org/wiki/Tuberculosis" \o "Tuberculosis" tuberculosis that is prepared from a strain of the live attenuated tuberculosis bacillus. Protection against disease is associated with a Th1 T-cell response involving interferon (IFN)-gamma-producing CD4+ T-cells. IFN-gamma has a key role in protective immunity through activation of macrophages. There are several reports of other effectors molecules and cells of the immune system that may play a role in protection against tuberculosis including TNF-�, IL-12, IL-17, IL-23, �/�T cells, NK T cells and regulatory T cells [25]. Mycobacterium tuberculosis is an aerobic, intracellular pathogen that stimulates both cellular and humoral immune responses. Clinical trials have confirmed that infection with mycobacteria other than M. tuberculosis, including the BCG vaccine, may induce some protection against tuberculosis. Artificial infection with BCG spreads from the inoculation site via the lymphatic system to local lymph nodes and produces an immunity equivalent to that produced by natural primary infection with virulent bacilli. As in the case of natural tuberculosis infection, the resistance is cell mediated and is largely attributable to activated macrophages. BCG-induced immunity develops about six weeks after vaccination [26]. For high-burden countries, WHO recommends vaccination as soon as possible after birth. The duration of protection after neonatal BCG vaccination is not well known but commonly believed to decline gradually to non-significant levels after 10�20 years [27]. 

Hepatitis B Immunity 
All infants should receive the hepatitis B vaccine; this is the mainstay of hepatitis B prevention. The vaccine can be given as either three or four separate doses, as part of existing routine immunization schedules. In areas where mother-to-infant spread of HBV is common, the first dose of vaccine should be given as soon as possible after birth (i.e. within 24 hours). Protection lasts at least 20 years and should be life long. If the mother is HBsAg positive, the baby should be given Hepatitis B Immune Globulin (HBIG) along with Hep B vaccine within 12 hours of birth, using two separate syringes and separate sites for injection. 

Haemophilus Influenzae type B immunity
Invasive Hib disease is predominantly a disease of early childhood. The incidence of Hib disease is relatively low in the first few months of life due to the transfer of maternal IgG specific for PRP across the placenta, although in some indigenous populations incidence of early invasive disease is high despite this antibody. Generally, once maternal antibodies wane, the incidence of disease increases, but by the age of five years the incidence of disease is universally low and remains low throughout adulthood with only a small increase in the incidence in the very elderly [28]. Like other bacterial-derived polysaccharides, PRP is classified as a T-independent antigen stimulating B cells directly without the help of T cells, and antigens of this type are known to be poorly immunogenic in childhood. Thus one of the reasons that young children are so susceptible to invasive Hib disease is that they are unable to mount robust responses to pure polysaccharide antigens before approximately 18 months of age.

Both humoral and cellular immune responses play an important role in individual protection against Hib disease. IgG, IgM and IgA antibodies to PRP may all be induced by infection as well as vaccination. A PRP antibody concentration of >0.15 m�g/ml is considered to be a serological marker for short-term protection; concentrations $1.0 m�g/ml 1 month after the completion of primary immunization are considered to be markers of long-term protective immunity against invasive Hib disease.

Pneumococcal immunity
The incidence is highest in early childhood and among the elderly, and in individuals with immune defects. The human nasopharynx is the only reservoir of pneumococci, which are transmitted by droplet spread between individuals. Carriage of pneumococci is most common during the first years of life, but varies between different geographical and socio-economic demographics. The etiology of pneumonia is difficult to establish, but recent vaccine trials suggest that a substantial proportion of pneumonia in young children is caused by the pneumococcus, killing annually an estimated 700 000 to one million children less than five years of age [29]. Since young adults respond satisfactorily to immunization of mothers has been considered as a protection for young infants against pneumococcal disease and colonization. Several studies show that infants of immunized mothers have elevated serum antibody concentrations up to four months after delivery [30, 31]. In addition to the transfer of antibodies through placenta breast milk, antibodies can be important for protection. The serological criteria defined by WHO include (a) the percentage of subjects with serotype-specific IgG e"0.35 �g/ml using a WHO reference assay (or an alternative and well-justified threshold value based on a specific in-house assay) and (b) the serotype-specific IgG geometric concentration ratios.

Rotavirus Immunity
Severe rotavirus disease in humans is most common between 6 and 24 months of age. The favoured explanation for the resistance of young infants to severe rotavirus disease is the presence of circulating transplacental neutralizing maternal antibody, and the onset of rotavirus disease in infants has been reported to coincide with the decline of maternal antibody titers [32]. Reduced severity of rotavirus disease in older children and adults is probably due primarily to immune responses stimulated by previous rotavirus infections. Protection against rotavirus infection and disease in previously-infected children and adults has been correlated with titers of circulating and intestinal rotavirus antibodies.

It remains to be determined however whether these antibodies are responsible for protection. Rotavirus infection normally provides short-term protection and immunity against severe subsequent illness but does not provide lifelong immunity; moreover, numerous cases of sequential illness have been reported. Protection against rotavirus infection is mediated by both humoral and cellular components of the immune system.


Conclusion
The protection against infection afforded by vaccination is one of the great successes of medicine. Over the past 20 years, immunization has prevented millions deaths from vaccine-preventable infections thus vaccines have prevented more deaths than any other medical measure so far. Today, most of the children receive these life-saving vaccinations and increasing numbers are also protected by new and under-used vaccines, like Hepatitis B. Protective immunity is about survival within an evolutionary context. It is particularly important early in life, because the immune system is juvenile at birth. Successful vaccines induce optimal levels of neutralizing antibodies against acutely cytopathic agents. At the same time innovative technology solutions that help to ensure vaccine effectiveness, efficiency, safety, and storage are enabling immunization programs to save even more lives. Without vaccines, as well as safe and effective vaccine distribution systems and delivery practices, disease would become more rampant, the public health system would be overburdened with treatment costs, and deaths�particularly in children�would increase dramatically. Immunization is therefore a valuable tool for protecting health, enhancing economic security and political stability, and saving lives.

Disclaimer: 
All opinions expressed herewith are those of the authors and do not reflect the views of their organization.

Conflict of interest
Nil








Reference
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Figure 1: Deaths due to vaccine-preventable diseases (in million)

  Source: Global Immunization Data, October 2012





























Table 1: Diseases & risk to young infants & children

DiseaseRisk to young infants & childrenDiphtheria Diphtheria is readily preventable by means of vaccination. In children younger than 5 who are not vaccinated, the mortality rate can be very high. Polio
(Poliomyelitis )Polio mainly affects children under five years of age. One in 200 infections leads to irreversible paralysis. Among those paralyzed, 5% to 10% die when their breathing muscles become immobilized.TetanusAny unimmunised person is at risk from tetanus including infants. The risk is greatest for the very young or aged over 60. Worldwide, about 50% of people who have tetanus die. Pertussis 
(whooping cough)Young infants are at highest risk from complications of this disease. Most deaths occur in infants under 1 year of age. Breastfeeding offers no protection from pertussis regardless of the mothers� immune status.MeaslesMeasles is one of the leading causes of death among young children even though a safe and cost-effective vaccine is available. In 2011, there were about 430 deaths every day or 18 deaths every hour from measles globally.Hepatitis BConsequences of hepatitis are inversely associated with age and 90% of infants during the first year of life may develop chronic infections associated morbidity and mortality. BCG
(Bacille Calmette
Gu�rin)In young children, haematogenous spread may result in severe primary disease, including miliary TB and TB meningitis. Neonates aged <6 weeks are regularly skin-test negative. RotavirusRotavirus is one of the most common causes of diarrhoea in children a"5NOPWabgopq�������������	2	<	������˿�������xngcngcgc\ncUcUch4zhh;5)
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Table 2: Correlates of vaccine induced immunity
VaccineVaccine typeSerum IgGMucosal IgGMucosal IgAT cellsDiphtheria toxoidtoxoid+ ++Tetanus Toxoidtoxoid+ +Measleslive attenuated + ++ (CD8+)   Pertussis, whole cellkilled+ +Pertussis, acellularprotein+ +Tuberculosis (BCG)live mycob+ + (CD4+)   Polio sabinlive attenuated + ++ ++ +Polio salkkilled+ ++ Pneumococcal  protein+ ++ +Rotaviruslive attenuated + +Hib-glycoconjugatesprotein+ ++ +Hepatitis B (HBsAg)protein+ +Yellow feverlive attenuated + + ++high, + moderate






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