We thank the readers for their interest in our work [1] and provide the
following clarifications: Regarding the inclusion criteria of
participants, we wish to clarify that HIV-infected children aged 18
months - 12 years who had been receiving ART for at least 6 months and
who had not received any prior dose of HBV vaccine were eligible,
provided they were seronegative (HBs antigen negative). Immunization
status for hepatitis B was assessed by studying the immunization cards
of the child as well as absence of anti-HBs antibodies. We had noticed
that the immunization records of some of these children were incomplete
due to reasons like relocation/ migration, or where the parents had
succumbed to HIV. Hence, relying solely on immunization records and
history, did not seem a robust method.
Although, hepatitis B vaccination had been introduced
in several Indian states almost a decade ago, the coverage of hepatitis
B vaccine was reported low with huge gaps in coverage of DPT3 and HBV3
persisting [2]. A survey from India [3], reported that in 2015-16, 45%
of the children aged 12-59 months were not fully vaccinated against
hepatitis B, and 20% children had not received even a single dose of
hepatitis B vaccine. Some of the participants in our study had been born
in remote rural areas and had later migrated to Delhi, and therefore had
not received hepatitis B vaccine. Some of these children had also not
received other vaccines; the missing vaccination doses were administered
by us during their visits to the anti-retroviral clinic.
The disparity in ages of participants in both groups
despite block randomization may have been due to the small sample size
and because we did not perform stratified randomization [4]. We excluded
20 children out of 70 eligible children. The CONSORT diagram depicts
that 20 children were excluded and also elucidates the reasons for
exclusion [1].
We agree that the research question addressed remains
unanswered. Finding even 50 children who had never received any dose of
hepatitis B vaccine was very challenging for us, and hence a convenience
sampling was done. This question may be answered by pooling similar data
from other studies and performing a meta-analysis.
1. Jain P, Dewan P, Gomber S, et al. Three vs four
dose schedule of double strength recombinant hepatitis-B vaccine in
HIV-infected children: A randomized controlled trial. Indian Pediatr.
2021;58:224-28.
2. Lahariya C, Subramanya BP, Sosler S. An assessment
of hepatitis B vaccine introduction in India: Lessons for roll out and
scale up of new vaccines in immunization programs. Indian J Public
Health. 2013;57:8-14.
3. Khan J, Shil A, Mohanty SK. Hepatitis B
vaccination coverage across India: Exploring the spatial heterogeneity
and contextual determinants. BMC Public Health. 20192;19:1263.
4. Broglio K. Randomization in clinical trials: Permuted blocks and
stratification. JAMA. 2018;319:2223-224.