الفهرس 
INTRODUCTIONOnly 14 pages are availabe for public view
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Abstract
The present study is considered a preliminary non-randomized clinical trial about the prevention of HBV vertical infection in Palestine.
The aim of the this study was to assess the effectiveness of HB vaccine alone versus HBIG combined with HB vaccine in the interruption of neonatal HB viral infection, to detect the difference in proportion of immune infants at 9 months of age among those receiving HB vaccine alone versus those receiving HBIG combined with HB vaccine, to determine the proportion of infants with HB virus infection in the two groups at 9 months of age, to explore the necessity for administration of a booster dose for the two groups and to evaluate which protocol is more suitable to be adopted in the Palestinian hospitals and Epidemiology departments.
The study design used was non-randomized clinical trial (non-inferiority study), along two groups:
The control group: newborns of mothers with inactive HBV infection were given HBIG and HB vaccine and,
The intervention group: newborns of mothers with inactive HBV infection were given HB vaccine alone.
The study was conducted in the five Epidemiology departments in GS and the delivery rooms in three governmental hospitals in GS.
The study sample was composed of 228 subjects with control-intervention ratio 1:1.
Participants were subjected to the following activities:
1. Using predesigned interviewing questionnaire
The questionnaire included questions related to:
• Questions related to the mothers which included: demographic variables, birth history variables, risk factors related variables and laboratory related variables.
• Questions related to the newborn which included: birth related variables, breast feeding variables, immune-prophylaxis variables and laboratory related variables.
2. Blood sampling for serological testing for HBsAg, HBeAg and LFT from the mothers prior or during delivery.
• Blood samples were withdrawn from the mothers and tested for HBsAg, HBeAg and LFT including ALT and AST. According to results the researcher had decided which subjects were included in the study and which immunization regimen was adopted.
• Only the newborns of mothers with positive for HBsAg and negative for HBeAg were included in the study.
3. Immunization of the newborns with HB vaccine with/ without combination of HBIG hastily post-delivery.
• Immunization with HB vaccine only to 114 newborns their mothers positive for HBsAg and negative for HBeAg. This immunization regimen was adopted at the epidemiology departments at the PHC directorates in the five governorates.
• Immunization with HB vaccine combined with HBIG to 114 newborns whose mothers were positive for HBsAg and negative for HBeAg. This immunization regimen was adopted at the delivery rooms in the governmental hospitals.
4. Blood sampling for serological testing for HBsAg and Anti-HBs titer to the infants after 9 months of age.
All of the two hundred twenty eight infants included in the study were tested for :
• HBsAg in order to identify the rate of HBsAg infection if any.
• HBsAb with the level of titration in order to identify the efficacy and immunogenicity of the immunization regimen.
5. No blood sampling for serological testing to infants with positive HBsAg results was done because no positive case were reported.
The study revealed the following results:
1. Detection of the difference of immunity among the infants at 9 months of age.
The results showed that the two immunization regimens were effective in preventing of the HB vertical infection and the adopted regimens give the infants the complete immune level (100 IU/L and more). GMT of the infants who vaccinated with HB vaccine alone (207.64 IU/L) was higher than the infants who vaccinated with HB vaccine combined with HBIG (180.87 IU/L), so the researcher ascertains that HB vaccine alone is not inferior to HB vaccine combined with HBIG in preventing the infection among the infants born to non- reactive HBV infected mothers.
The overall vaccine protection rate in this study was 93.4% (213/228) achieved a protective level of more than 10 IU/L at 9 months of age.
2. Determination of the proportion of infants with HB virus infection at 9 months of age.
The study didn`t report any HBV infected cases, so HBV incidence rate was zero %, this indicates the success of the immunization regimens intervened to babies of HBsAg positive and HBeAg negative mothers.
3. Detection the level of response to the immunization regimens.
All the infants (228/228) 100 % were responsive to the immunization regimen, while 6.6 % didn`t get the protection level of Anti-HBs higher than 10 IU/L.
The overall incidence of non-protection among both groups was 6.57 % and it was higher (7.89 %) among the infants vaccinated with HB vaccine combined with HBIG compared to the infants vaccinated with HB vaccine alone (5.26 %), RR 2.63.
No statistically significant differences were found between non-protected infants and the following risk factors: familial socio-demographic variables, mother’s infection status, mother’s age, delivery variables, antenatal care related variables, child’s sex, child’s weight, type of prophylaxis and place of vaccination.
4. The necessity to administer HB vaccine booster dose.
The results revealed that no need for booster dose to 93.4 % infants because they got the protection level higher than 10 IU/L Anti-HBs titer, and revaccination to 6.6 % of non- protected infants was recommended and intervened.
Anti-HBs titer may decrease over time after vaccination, after five years a booster dose could be needed, so further research may be needed to decide whether HB vaccine booster dose is needed or not.
5. Evaluating the adopted protocols in the Palestinian hospitals and Epidemiology departments.
The study revealed that there is double policy in the Palestinian governmental health sector. The GMT among the infants immunized in the epidemiology departments with HB vaccine alone was 207.64 IU/L higher than the GMT in the hospitals 180.87 IU/L.
Gaza`s hospitals policy is more expensive comparable to the epidemiology departments policy, so the hospitals policy should be unified with the policy of the epidemiology departments which is considered more cost effective.
6. HBV infection and breastfeeding.
In this study there is no evidence that breastfeeding increases the risk of MTCT, so the researcher demonstrated that breastfeeding is not contraindicated to infants born to mothers who are HBsAg positive according to the study results.
The results showed that 99.6 % of the mothers breast fed their babies and no one case of HB infection was reported. So the researcher encourage HBV-infected mothers to breastfeed their infants.
The following are recommendations of the study:
HB vaccine immunization regimen completely prevents against HBV vertical infection and is not inferior to HB vaccine combined with HBIG regimen.
The Palestinian health officials are recommended to save the money by changing the policy of the hospitals and following the policy of the Epidemiology departments.
Post vaccination testing to assess the immunization response should be done at 9-18 months of age.
The researcher recommends that there is no need to delay breastfeeding until the infant is fully immunized.
Further research is required to decide whether booster dose is needed after five years or not.
Conducting of further research in order to assess the relationship of immunization response with the breastfeeding.
Conclusion
Based upon the results of the current study it can be concluded that:
HB vaccine alone is not inferior to HB vaccine combined with HBIG in preventing the vertical infection among non-reactive HBV infected mothers.
The adopted regimens were perfect in preventing the occurrence of vertical HBV infection.
The level of immunity was affected positively when the vaccination was given directly post- delivery.
No need for booster dose of HB vaccine at least for five years for the infants their Anti-HBs was not less than 10 IU/L.
Breast feeding is not prohibited if the babies of the HBV infected mothers immunized directly after delivery.
The immunization regimen which was adopting in the Epidemiology departments was more cost effective than the regimen was adopting in the hospitals.
The GMT among the infants immunized in the epidemiology departments with HB vaccine alone was 207.64 IU/L, higher than the GMT in the hospitals 180.87 IU/L.
Recommendations
The following are recommendations of the study:
Immunization regimen recommendations
•HB vaccine immunization regimen is completely preventive against HBV vertical infection and not inferior to HB vaccine combined with HBIG regimen.
•The Palestinian health officials are recommended to save the money by changing the policy of the hospitals and following the policy of the epidemiology departments.
•Assessing the protection rate among the non-respondent infants after 3 months from the last dose.
•Providing of HBIG to infants born to inactive HB infected mothers is costly and will add only modestly to disease prevention
•HBIG to be given as soon as possible at the first 2 hours of life, because no efficacy was found if HBIG was given more than 7 days after birth, and a significant decrease in efficacy was observed if it was given more than 48 hours after birth.
•Assuring the continuity of the expanded program of immunization as well as HB vaccination.
•Complete vaccine series by six months of age.
• Mass immunization of all risky groups in order to control the infection and decrease the prevalence of the disease.
•Provision of suitable stock of HBIG and HB vaccine at separate facilities as well as the epidemiology departments and the delivery units in the hospitals.
Breastfeeding recommendations
•The researcher recommends that there is no need to delay breastfeeding until the infant is fully immunized.
•Women who are HB positive carriers should be advised not to donate breast-milk.
Clinical and laboratory follow up recommendations
•Post-vaccination testing for anti-HBs and HBsAg should be performed after completion of the vaccine series, at age 9-18. Testing should not be performed before age 9 months to avoid detection of anti-HBs from HBIG administered during infancy and to maximize the likelihood of detecting late HBV infection.
If HBsAg-negative infants with anti-HBs levels >10 IU/L considered as protected and no need for further medical management.
If HBsAg-negative infants with anti-HBs levels <10 IU/L should be revaccinated with a second 4-dose series and retested 1-2 months after the final dose of vaccine.
If Infants who are HBsAg positive should receive appropriate follow-up.
•Clinical evaluations to detect the onset and progression of HBV-related liver disease.
•Proper treatment for HBV infection which can delay or reverse the progression of liver disease.
HBV screening recommendations
•All pregnant women should be routinely screened for HBsAg regardless of previous testing or vaccination.
•Assuring that all women receiving prenatal care in both public and private sector programs must be freely screened.
•All HBsAg-positive women should be tested for HBeAg and liver function tests in the last trimester of pregnancy in order to decide which prophylaxis regimen to be adopted.
•Invasive procedures fetal scalp blood sampling should be avoided during pregnancy.
•Household members of HBV carriers identified through prenatal screening should be tested to determine susceptibility to HBV infection and should receive HB vaccine.
•Ongoing monitoring and investigation of the Anti-HBs titer level in children and other ages to ensure protective level of immunity.
Laboratory related recommendations
•Hospitals where infants are delivering should have HBsAg and HBeAg testing capabilities.
•If a serum specimen is positive for HBsAg, the same specimen should be tested again, and then the test results should be confirmed by neutralization.
Care of the neonate at risk for perinatal transmission of HBV recommendations
•Universal precautions should be utilized as for all neonates.
•Prior to administering injections the neonate should be bathed, or the injection site cleansed with an alcohol swab.
Health education, coordination and counseling recommendations
•Programs to coordinate the activities of those providing epidemiological, prenatal care, hospital- based obstetrical services, and pediatric well-baby care must be established to assure proper follow-up and treatment of infants born to HBsAg- positive mothers and other susceptible household contacts.
•Hospitals and epidemiology departments should establish programs to educate appropriate health-care providers about perinatal transmission of HBV and its control through maternal screening, treatment of infants, and vaccination of susceptible household contacts of HBV carrier women.
•Health education and public awareness programs that include information regarding the rationale for and importance of newborn HB vaccination and prevention strategies..
•Adoption of capacity building programs to the health professionals as well as epidemiologists and obstetrician to be aware with the HBV infection updates.
•Involvement with a support group might help infected mothers to cope with chronic HBV infection through specific and specialized institutions.
•Ensure the mother is aware of the follow-up vaccination regimen, and need for epidemiologist review to assess anti-HBs and HBsAg levels for the baby.