|
Lancet 1997 May 3;349(9061):1277-1281 |
Randomised double-blind placebo-controlled
study on adverse effects of rubella immunisation in seronegative women.
Tingle AJ, Mitchell LA, Grace M, Middleton P, Mathias R, MacWilliam L,
Chalmers A.
Department of Paediatrics, University of British Columbia, Vancouver, Canada.
BACKGROUND: The objective of our study was to investigate the association of
adverse clinical musculoskeletal and neurological events in healthy postpartum
women with live attenuated (RA27/3 strain) rubella-virus vaccine, and to assess
the frequency of acute and recurrent arthralgia and arthritis and associations
with acute and recurrent muscle pain (myalgia) and neurological manifestations
(paraesthesias). METHODS: We used a randomised placebo-controlled, double-blind
design in a community setting. 636 women were enrolled and, after 90 women
dropped out, 546 healthy women aged 18-41 years, who were rubella seronegative
on routine screening were immunised parenterally with either monovalent live
attenuated (RA27/3 strain) rubella vaccine (n = 270) or saline placebo (n =
276) in the postpartum period. Outcome measures were the occurrence of acute
and persistent or recurrent joint manifestations (arthralgia or arthritis) at
1, 3, 6, 9, and 12 months after immunisation. Occurrence of muscle pain
(myalgia), and neurological symptoms (paraesthesia) was also assessed at the
same times. FINDINGS: 543 women completed 1-month follow-up. 456 women
completed the 12-month assessment. There were no differences at the time of
immunisation between rubella vaccine and placebo groups in distribution of age,
ethnic origin, parity, time between delivery and immunisation, breastfeeding
history, or histories of earlier rubella vaccination or joint complaints.
Results indicated a significantly higher incidence (p = 0.006; odds ratio =
1.73 [95% CI = 1.17-2.57]) of acute joint manifestations in rubella-vaccine
recipients (30%) than in placebo recipients (20%). Frequency of chronic
(recurrent) arthralgia or arthritis was only marginally significant (p = 0.042;
1.58 [1.01-2.45]). INTERPRETATION: RA27/3 rubella vaccine given to seronegative
women during the postpartum period was significantly associated with
development of acute arthralgia or arthritis. Although the numbers of women assessed
and length of follow-up revealed only marginally significant differences in
persistent or recurrent joint manifestations between rubella vaccine and
placebo recipients, it is possible that susceptible women who are given rubella
vaccination may experience this outcome.
Publication Types:
·
Clinical trial
·
Randomized controlled trial
PMID: 9142061 [PubMed - indexed for MEDLINE]
ALL
INFORMATION, DATA, AND MATERIAL CONTAINED, PRESENTED, OR PROVIDED HERE IS FOR
GENERAL INFORMATION PURPOSES ONLY AND IS NOT TO BE CONSTRUED AS REFLECTING THE
KNOWLEDGE OR OPINIONS OF THE PUBLISHER, AND IS NOT TO BE CONSTRUED OR INTENDED
AS PROVIDING MEDICAL OR LEGAL ADVICE. THE DECISION WHETHER OR NOT TO
VACCINATE IS AN IMPORTANT AND COMPLEX ISSUE AND SHOULD BE MADE BY YOU, AND YOU
ALONE, IN CONSULTATION WITH YOUR HEALTH CARE PROVIDER.