What is the clinical evidence from this study?

Study design: RCT. Population: Healthy neonates (n=240). Intervention: Live oral tetravalent human-rhesus rotavirus reassortant vaccine vs. Placebo. Primary outcome: Seroresponse of any type (detectable IgA or 4-fold increase of titer to rhesus rotavirus).

What does this research mean for the field?

Live oral tetravalent human-rhesus rotavirus reassortant vaccine administered to neonates is safe and induces a seroresponse in approximately half of recipients compared to 9% with placebo, but fails to generate neutralizing antibodies against human rotavirus serotypes 1, 2, and 3. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

December 1, 1992The Pediatric Infectious Disease Journal

Safety and immunogenicity of oral tetravalent human-rhesus reassortant rotavirus vaccine in neonates

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Key result

Live oral tetravalent rotavirus vaccine elicits seroresponse in ~52% of one-dose recipients versus placebo.

n=240

Why the study?

Does live oral tetravalent human-rhesus rotavirus reassortant vaccine improve immunogenicity and is it safe in healthy neonates?

Population

240 healthy neonates

Comparison

Live oral tetravalent human-rhesus rotavirus… vs Placebo

Design

RCT, randomized, double blind

Follow-up

1 year

Authors

RDRon DaganBen-Gurion University of the Negev IKImad KassisRambam Health Care Campus BSBatia SarovBen-Gurion University of the Negev

Discussion

Member takes

Implication

Safe but induces only partial seroresponse without human serotype neutralization; extends early immunogenicity data without supporting neonatal use.

Study Design

Type

RCT (n=240)

Blinding

Double-blind

Randomization

randomized

Structured PICO

Does live oral tetravalent human-rhesus rotavirus reassortant vaccine improve immunogenicity and is it safe in healthy neonates?

Population

240 healthy neonates randomized to receive oral tetravalent human-rhesus rotavirus vaccine or placebo on the second day of life, with follow-up to 1 year.

Intervention

Live oral tetravalent human-rhesus rotavirus reassortant vaccine (first dose on second day of life, with a subset receiving a second dose at 6 to 8 weeks of age)

Comparator

Placebo

Outcome

Safety (medical events within 10 days from vaccine administration) and immunogenicity (seroresponse of any type, neutralizing antibodies)safety

Main Result

Absolute Event Rate: 52% vs 9%

The oral tetravalent human-rhesus rotavirus vaccine was safe in neonates and induced antirhesus rotavirus antibodies, but failed to raise neutralizing antibodies against human serotypes 1, 2, and 3.

Cite This Study

Dagan et al. (1992) conducted an RCT in Healthy neonates (n=240). Live oral tetravalent human-rhesus rotavirus reassortant vaccine vs. Placebo was evaluated on Seroresponse of any type (detectable IgA or 4-fold increase of titer to rhesus rotavirus). Live oral tetravalent human-rhesus rotavirus reassortant vaccine elicited a seroresponse in 52% of one-dose and 46% of two-dose recipients compared to 9% for placebo.

synapsesocial.com/papers/6aa658ba22b0548423396d97 https://doi.org/10.1097/00006454-199211120-00001

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Implication

Safe but induces only partial seroresponse without human serotype neutralization; extends early immunogenicity data without supporting neonatal use.

Safety and immunogenicity of oral tetravalent human-rhesus reassortant rotavirus vaccine in neonates

Discussion

Member takes

Implication

Study Design

Structured PICO

Main Result

Cite This Study

Safety and immunogenicity of oral tetravalent human-rhesus reassortant rotavirus vaccine in neonates

Discussion

Member takes

Implication

Study Design

Structured PICO

Main Result

Cite This Study

Also Consider

Also Consider