Evidence map›Paper›PMID 32851202›Full record

ArticleTherapeutic advances in vaccines and immunotherapy2020

Evaluation of immunogenicity, safety and breakthrough following administration of live attenuated varicella vaccine in two doses three months apart regimen in Indian children.

Monjori Mitra, Jaydeep Chowdhury, Surupa Basu, Partha Pratim Halder, Mallar Mukherjee, Archana Karadkhele, Gaurav Puppalwar, Rishi Jain

Open access · diamondAbstract read
In one paragraph

Article in Therapeutic advances in vaccines and immunotherapy, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.3field-weighted citation impact, top 40% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 2 citations in OpenAlex.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 2 institutions in 1 country.

Monjori MitraInstitute of Child Health, Kolkata, India.
Jaydeep ChowdhuryInstitute of Child Health, Kolkata, India.
Surupa BasuInstitute of Child Health, Kolkata, India.
Partha Pratim HalderInstitute of Child Health, Kolkata, India.
Mallar MukherjeeInstitute of Child Health, Kolkata, India.
Archana KaradkheleMedical Affairs Division, Wockhardt Ltd., 1st Floor, West Wing, Wockhardt Global Headquarters, Bandra Kurla Complex, Bandra (East), Mumbai-51, India.ORCID https://orcid.org/0000-0003-4727-487X
Gaurav PuppalwarMedical Affairs Division, Wockhardt Ltd., Mumbai, India.
Rishi JainMedical Affairs Division, Wockhardt Ltd., Mumbai, India.
Institute of Child Health · INWockhardt Hospitals · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn India, where varicella outbreaks are reported at a younger age, a two-dose vaccine schedule administered at an early age could be highly efficacious in preventing varicella infection. The aim of this study was to evaluate the immunogenicity and safety of live attenuated varicella vaccine (VR 795 Oka strain) in a two-dose, 3 months apart regimen. METHODOLOGY: Healthy children (⩾ 12 months and ⩽12 years; mean age: 4.4 years) of either sex were included. Geometric mean titers (GMT) were measured at baseline and 28 days post first- and second-dose, and seroprotection rates were measured 28 days post first and second dose. The incidence of breakthrough (BT) infections post vaccination was determined from 42 days post first and second dose of vaccine up to 12 months. Adverse events (AEs) were monitored and recorded throughout the study period.

resultsOf 305 subjects enrolled, 217 were seronegative. The seroconversion rate (a change from a seronegative to a seropositive condition) was 93.3% post first-dose and 100% post two-doses. High levels (9 times) of GMT were reported since post first-dose to post second-dose in children aged 12-18 months, 18-60 months (99.43%); and in and above 60 months (99.02%). The extent of rise of anti-VZV IgG antibody titer post 28 days of first-dose at two-fold, three-fold and four-fold rise was 93.39%, 90.56% and 80.66%, respectively and 100% 4-fold rise post second-dose. A single case, a day after the first-dose of vaccination of mild BT infection, was observed after close contact with a severe case. AEs were mild and none of the serious AEs were related to the study drug.

conclusionThe two-dose schedule of varicella vaccine was safe and immunogenic when given 3 months apart. However, further comparative studies and follow up for both dosing schedules are needed to validate the advantage of early dosing.

Indexed as

antibody titerbreakthroughseroprotectionvaccinevaricella

Identifiers

PMID32851202
PMCPMC7425319
OpenAlexW3048888354

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.