With respect to the recent publication by Jain, et
al. [1] on the above topic, we seek the following clarifications:
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 1-2 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.
