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Rotavirus Vaccine Can Be Safely Co-Administered With Standard Childhood Vaccines: Presented at ESPID

By Neil Osterweil

GRAZ, Austria -- May 22, 2008 -- A pentavalent rotavirus vaccine can be safely co-administered with a combined vaccine against diphtheria, tetanus, pertussis, hepatitis B, poliovirus, and Haemophilus influenzae type b with no apparent dampening of immunogenicity of any of the constituent antigens, it was reported here at the 26th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID).

A randomised, double-blind, clinical trial compared rotavirus vaccination with placebo when coadministered with a 3-dose primary course of a hexavalent diphtheria-tetanus-acellular pertussis/hepatitis B/inactivated poliovirus/H influenzae type b (DTaP-HBV-IPV/Hib) vaccine used in some European countries.

The findings were described in a poster session here on May 14 by Max Ciarlet, PhD, Associate Director, Vaccine & Biologics – Clinical Research, Merck Research Laboratories, North Wales, Pennsylvania.

A total of 403 healthy infants were randomised to receive either rotavirus vaccine or placebo concomitantly with the DTaP-HBV-IPV/Hib vaccine at 2, 3, and 4 months of age.

Immune responses for DTaP-HBV-IPV/Hib were measured after dose 3 with geometric mean titres (GMTs) for all antigens. Seroprotection rates, determined by postdose 3 serum antibody, were measured as 10 mIU/mL for HBV; 0.15 mcg/mL for polyribosylribitol/Hib; 0.01 IU/mL for diphtheria and tetanus toxoids; and a neutralising antibody ratio of 1:8 for poliovirus types 1, 2, and 3.

For the rotavirus, Dr. Ciarlet and colleagues measured postdose 3 GMTs and seroresponse rates as a 3-fold rise from baseline in serum antirotavirus IgA and rotavirus serum neutralising antibody. Adverse events were recorded for 2 weeks after each vaccination visit.

The team found that the rotavirus vaccine was well tolerated, with no deaths or cases of intussusception reported. Reported frequencies of clinical adverse events were similar between the 2 groups.

Antibody responses and seroprotection rates against all antigens of DTaP-HBV-IPV/Hib were similar between the children who received the rotavirus and controls at 42 days, following the third dose.

Among the patients who received the rotavirus vaccine, the seroresponse rate of serum antirotavirus IgA was approximately 92% compared with about 6% among patients who were injected with placebo.

Rotavirus serum neutralising antibody responses were also statistically higher in the rotavirus group compared with controls.

The authors concluded that concomitant administration of the pentavalent rotavirus vaccine with DTaP-HBV-IPV/Hib was well tolerated, was immunogenic against rotavirus, and did not impair the immune response of any of the coadministered antigens.

This study was funded by Merck & Co., Inc.


[Presentation title: Coadministration of the Pentavalent Rotavirus Vaccine, Rotateq, With a Three-Dose Primary Course of a DTaP-HBV-IPV/Hib Hexavalent Vaccine: Immunogenicity and Reactogenicity. Abstract 604]

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