Three vs Four Dose Schedule of Hepatitis-B Vaccine in HIV-infected Children

Abstract

mentions trial participants being fifty (25 per group) HIV-infected children aged 18 months 12 years receiving ART for at least 6 months who had not received any prior dose of HBV vaccine, and were anti-HBs negative [1]. While in methods section it is mentioned as participants being seronegative for Hepatitis B virus (HBs antigen negative). Were participants anti-HBs antibody titre negative or HBsAg antigen negative? Or both antigen and antibody negative? Please clarify this confusion. Regarding immunization status of participants, methods section mentions that immunization status was ascertained on the basis of previous immunization records [1]. Hepatitis B vaccination in immunization schedule of Delhi was introduced more than a decade ago [2]. So either participants were completely unvaccinated for all vaccines or vaccinated for all vaccines along with hepatitis B, depending on at what age they voluntarily stopped getting vaccines intentionally. So, no immunization record with no history of immunization too would have been a better proxy for unvaccinated subjects. How participants were left out for hepatitis B vaccine only? A previous randomized trial on similar topic [3] had subjects that were older, as routine hepatitis B vaccination had started just 12 years prior to the study. Due to the convenience sampling, it is still unclear if double strength (20 μg) 4-dose schedule (0, 1, 2 and 6 months) is equally efficacious or superior to 3-dose schedule (0, 1 and 6 months), as the study was not powered to detect a difference unanswered thereby leaving this important question. Baseline characteristics table shows mean age of groups I and II being 7 and 11 years, respectively [1]. It seems to differ significantly despite SNOSE technique and block randomization. Moreover, CONSORT flow chart shows 70 participants being eligible. While during enrollment, 40 (on summing up) were excluded. SHAHID AKHTAR SIDDIQUI1* AND GULNAZ FATIMA SIDDIQUI2 1Department of Pediatrics, MLN Medical College, Allahabad; 2Department of Medicine, CRIUM Hyderabad, India.