Immunogenicity and safety of measles-mumps-rubella vaccine delivered by disposable-syringe jet injector in India: A randomized parallel group non-inferiority trial.

Friday, 2nd of March 2018 Print

Vaccine. 2018 Feb 21;36(9):1220-1226. doi: 10.1016/j.vaccine.2018.01.006. Epub 2018 Feb 1.

Immunogenicity and safety of measles-mumps-rubella vaccine delivered by disposable-syringe jet injector in India: A randomized parallel group non-inferiority trial.

Bavdekar A1 Oswal J2 Ramanan PV3 Aundhkar C4 Venugopal P5 Kapse D6 Miller T7 McGray S8 Zehrung D8 Kulkarni PS9; SII MMR author group.

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Abstract

BACKGROUND:

We conducted a randomized non-inferiority clinical study of MMR vaccine by a disposable-syringe jet injector (DSJI) in toddlers in India in comparison with the conventional administration.

METHODS:

MMR vaccine was administered subcutaneously by DSJI or needle-syringe (N-S) to toddlers (15-18 months) who had received a measles vaccine at 9 months. Seropositivity to measles mumps and rubella serum IgG antibodies was assessed 35 days after vaccination. Non-inferiority was concluded if the upper limit of the 95% CI for the difference in the percent of seropositive between groups was less than 10%. Solicited reactions were collected for 14 days after vaccination by using structured diaries.

RESULTS:

In each study group 170 subjects received MMR vaccine. On day 35 seropositivity for measles was 97.5% [95% CI (93.8% 99.3%)] in the DSJI group and 98.7% [95% CI (95.5% 99.8%)] in the N-S group; for mumps 98.8% [95% CI (95.6% 99.8%)] and 98.7% [95% CI (95.5% 99.8%)]; and for rubella 98.8% [95% CI (95.6% 99.8%)] and 100% [95% CI (97.7% 100.0%)]; none of the differences were significant. The day 35 post-vaccination GMTs in DSJI and N-S groups were measles: 5.48 IU/ml [95% CI (3.71 8.11)] and 5.94 IU/ml [95% CI (3.92 9.01)] mumps: 3.83 ISR [95% CI (3.53 4.14)] and 3.66 ISR [95% CI (3.39 3.95)] and rubella: 95.27 IU/ml [95% CI (70.39 128.95)] and 107.06 IU/ml [95% CI (79.02 145.06)]; none of the differences were significant. The DSJI group reported 173 solicited local reactions and the N-S group reported 112; most were mild grade. Of the total of 156 solicited systemic adverse events most were mild and incidence between the two groups was similar.

CONCLUSIONS:

MMR vaccination via DSJI is as immunogenic as vaccination by N-S. Safety profile of DSJI method is similar to N-S except for injection site reactions which are more with DSJI and are well-tolerated. Registration US National Institutes of Health clinical trials identifier - NCT02253407. Clinical trial registry of India identifier - CTRI/2013/05/003702.

Copyright © 2018 The Author(s). Published by Elsevier Ltd.. All rights reserved.

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