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Randomized Controlled Trial
. 2014;10(8):2267-75.
doi: 10.4161/hv.29176.

Analysis by rotavirus gene 6 reverse transcriptase-polymerase chain reaction assay of rotavirus-positive gastroenteritis cases observed during the vaccination phase of the Rotavirus Efficacy and Safety Trial (REST)

Affiliations
Randomized Controlled Trial

Analysis by rotavirus gene 6 reverse transcriptase-polymerase chain reaction assay of rotavirus-positive gastroenteritis cases observed during the vaccination phase of the Rotavirus Efficacy and Safety Trial (REST)

David O Matson et al. Hum Vaccin Immunother. 2014.

Abstract

During the vaccination phase of the Rotavirus Efficacy and Safety Trial (REST), the period between the administration of dose 1 through 13 days after the administration of dose 3, there were more wild-type rotavirus gastroenteritis (RVGE) cases among vaccine recipients compared with placebo recipients using the protocol-specified microbiological plaque assay in the clinical-efficacy cohort, a subset of subjects where vaccine efficacy against RVGE of any severity was assessed. In this study, a rotavirus genome segment 6-based reverse transcriptase-polymerase chain reaction assay was applied post hoc to clarify the accuracy of type categorization of all these RVGE cases in vaccine recipients during the vaccination phase of REST. The assay characterized 147 (90%) of 163 re-assayed RVGE cases or rotavirus-associated health care contacts as type-determinable: either wild-type or vaccine-type rotavirus strains. In the clinical-efficacy cohort (N = 5673), 19 (18.8%) of 101 samples from RVGE cases contained wild-type rotavirus, 70 (69.3%) vaccine virus, and 12 (11.9%) were indeterminable. In the large-scale cohort (N = 68,038), 10 (34.5%) of 29 samples from RVGE-related health care contacts contained wild-type rotavirus strains, 15 (51.7%) vaccine-type rotavirus strains, and 4 (13.8%) were indeterminable. Of the 33 samples from RVGE cases in placebo recipients, all were confirmed to contain wild-type rotaviruses. Altogether, this post-hoc re-evaluation showed that the majority (75%) of type-determinable RVGE cases or health care contacts that occurred during the vaccination phase of REST in vaccine recipients were associated with vaccine-type rotavirus strains rather than wild-type rotavirus strains.

Keywords: RV5; Rotavirus gastroenteritis; plaque assay; rotavirus gene 6 RT-PCR; vaccine-type; wild-type.

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Figures

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Figure 1. Categorization by the gene 6-based RT-PCR assay of rotavirus-positive stool samples collected during the vaccination phase of REST among all infants who received at least 1 dose of vaccine or placebo. All specimens were characterized as wild-type by the microbiological plaque assay. (A) Categorization of rotavirus cases among participants in the clinical-efficacy cohort of REST. (B) Categorization of samples collected during rotavirus-associated health care contacts (hospitalization or ED visit) during the vaccination phase among all participants in the large-scale cohort of REST. REST, Rotavirus Efficacy and Safety Trial; RV5, pentavalent rotavirus vaccine; EIA, enzyme immunoassay. RT-PCR, reverse transcriptase–polymerase chain reaction; ED, emergency department.
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Figure 2. Summary of the re-categorization by the gene 6 RT-PCR assay of EIA rotavirus-positive stool samples collected during the vaccination phase of REST from infants who received at least 1 dose of RV5 or placebo. (A) RVGE cases among participants in the clinical-efficacy cohort of REST. (B) RVGE-attributable health care contacts (hospitalization or ED visit) among all participants in the large-scale cohort of REST. The trends observed in the clinical-efficacy cohort were observed in the large-scale cohort, but severity of illness was greater in participants hospitalized or taken to EDs than in the clinical-efficacy cohort and health care contacts were fewer in number than in the clinical-efficacy cohort. REST, Rotavirus Efficacy and Safety Trial; RV5, pentavalent rotavirus vaccine; EIA, enzyme immunoassay. RT-PCR, reverse transcriptase–polymerase chain reaction; ED, emergency department.
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Figure 3. Overview of REST and EIA rotavirus-positive stool samples collected during the vaccination phase of the trial. (A) In REST, the clinical-efficacy cohort was nested within the large-scale cohort. (B) The vaccination phase began the day of administration of dose 1 through 13 d after the administration of dose 3. Dose 1 was administered at 6 to 12 wk of age, dose 3 was administered no later than 32 wk of age, and the interval between doses was 4 to 10 wk. The per-protocol primary monitoring period for vaccine efficacy began 14 d after dose 3, i.e., once the vaccination phase was completed. (C) Flowchart indicating the number of EIA rotavirus-positive stool samples collected from RV5 and placebo recipients during the vaccination phase of REST. The number of samples re-tested by the gene 6 RT-PCR assay is indicated at the bottom. REST, Rotavirus Efficacy and Safety Trial; EIA, enzyme immunoassay.

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