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Use of a reformulated Oka strain varicella vaccine (SmithKline Beecham Biologicals/Oka) in healthy children

Use of a reformulated Oka strain varicella vaccine (SmithKline Beecham Biologicals/Oka) in healthy children
Use of a reformulated Oka strain varicella vaccine (SmithKline Beecham Biologicals/Oka) in healthy children

The first live-attenuated Oka strain varicella vaccines needed to be stored at -20°C. Reformulation of this vaccine by SmithKline Beecham Biologicals has provided a vaccine shelf life of up to 2 years when stored at +2°C to +8°C. In this study the immunogenicity and reactogenicity of two different production lots of this reformulated vaccine at two different titres each, which corresponded to the release and expected expiry titres, were evaluated. A double-blind randomised clinical trial was conducted in healthy children aged from 9 to 24 months. Immunogenicity was assessed by the measurement of varicella specific antibodies in paired serum samples taken before and from 35 to 63 days post vaccination. Reactogenicity was assessed by the evaluation of any untoward reactions occurring up to 42 days post vaccination. In order to assess protective efficacy, parents of these subjects were contacted approximately 6 months after completion of the trial. One hundred and ninety-one subjects were recruited into the study. Of the 181 initially seronegative subjects who completed the trial according to the protocol, 179 showed seroconversion (98.9%). Reactions to the vaccine were minor and observed in 46/191 (24%) of subjects. Rashes were present in 19, fever in 22, and both fever and rashes in 5. Rashes were mainly maculo-papular in nature but were vesicular in 6. Febrile reactions were shortlived. After a 6-month follow up period, attenuated varicella with minor clinical symptoms was diagnosed in 6/52 vacinees who had close contact with natural varicella (attack rate = 11.5%). Conclusion. This reformulated vaccine was well tolerated, highly immunogenic and provided protection against varicella. Its increased stability allowing refrigerator storage makes it a good candidate for mass vaccination programmes.

Children, Immunogenicity, Reactogenicity, Seroconversion, Varicella vaccine
0340-6199
706-711
Tan, A. Y.S.
533c9b85-f01c-4158-827d-e48da1c01c12
Connett, C.J.
63166da8-7c2c-44ae-9d7a-9ec0579796dc
Connett, G.J.
55d5676c-90d8-46bf-a508-62eded276516
Quek, S.C.
d359ea40-f736-485a-abce-cd5ed6fdd18a
Yap, H.K.
af5eb837-c65d-4b34-986f-66d2cfd3da51
Meurice, F.
e529db52-1c35-4b67-97f3-3f2c24d401c8
Lee, B.W.
643a0988-a441-4752-a190-e1e392c98738
Tan, A. Y.S.
533c9b85-f01c-4158-827d-e48da1c01c12
Connett, C.J.
63166da8-7c2c-44ae-9d7a-9ec0579796dc
Connett, G.J.
55d5676c-90d8-46bf-a508-62eded276516
Quek, S.C.
d359ea40-f736-485a-abce-cd5ed6fdd18a
Yap, H.K.
af5eb837-c65d-4b34-986f-66d2cfd3da51
Meurice, F.
e529db52-1c35-4b67-97f3-3f2c24d401c8
Lee, B.W.
643a0988-a441-4752-a190-e1e392c98738

Tan, A. Y.S., Connett, C.J., Connett, G.J., Quek, S.C., Yap, H.K., Meurice, F. and Lee, B.W. (1996) Use of a reformulated Oka strain varicella vaccine (SmithKline Beecham Biologicals/Oka) in healthy children. European Journal of Pediatrics, 155 (8), 706-711. (doi:10.1007/s004310050473).

Record type: Article

Abstract

The first live-attenuated Oka strain varicella vaccines needed to be stored at -20°C. Reformulation of this vaccine by SmithKline Beecham Biologicals has provided a vaccine shelf life of up to 2 years when stored at +2°C to +8°C. In this study the immunogenicity and reactogenicity of two different production lots of this reformulated vaccine at two different titres each, which corresponded to the release and expected expiry titres, were evaluated. A double-blind randomised clinical trial was conducted in healthy children aged from 9 to 24 months. Immunogenicity was assessed by the measurement of varicella specific antibodies in paired serum samples taken before and from 35 to 63 days post vaccination. Reactogenicity was assessed by the evaluation of any untoward reactions occurring up to 42 days post vaccination. In order to assess protective efficacy, parents of these subjects were contacted approximately 6 months after completion of the trial. One hundred and ninety-one subjects were recruited into the study. Of the 181 initially seronegative subjects who completed the trial according to the protocol, 179 showed seroconversion (98.9%). Reactions to the vaccine were minor and observed in 46/191 (24%) of subjects. Rashes were present in 19, fever in 22, and both fever and rashes in 5. Rashes were mainly maculo-papular in nature but were vesicular in 6. Febrile reactions were shortlived. After a 6-month follow up period, attenuated varicella with minor clinical symptoms was diagnosed in 6/52 vacinees who had close contact with natural varicella (attack rate = 11.5%). Conclusion. This reformulated vaccine was well tolerated, highly immunogenic and provided protection against varicella. Its increased stability allowing refrigerator storage makes it a good candidate for mass vaccination programmes.

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More information

Published date: August 1996
Keywords: Children, Immunogenicity, Reactogenicity, Seroconversion, Varicella vaccine

Identifiers

Local EPrints ID: 420688
URI: https://eprints.soton.ac.uk/id/eprint/420688
ISSN: 0340-6199
PURE UUID: 814e92b0-220d-4f4a-8302-75569df7efe1
ORCID for G.J. Connett: ORCID iD orcid.org/0000-0003-1310-3239

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Date deposited: 11 May 2018 16:30
Last modified: 20 Jul 2019 00:23

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Contributors

Author: A. Y.S. Tan
Author: C.J. Connett
Author: G.J. Connett ORCID iD
Author: S.C. Quek
Author: H.K. Yap
Author: F. Meurice
Author: B.W. Lee

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