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Investigational vaccine shows promise
Tregnaghi M. Pediatr Infect Dis J. 2011;doi:10.1097/INF.0b013e318242460a.
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A new pentavalent vaccine appears to be safe and immunogenic, according recent study findings from Argentina.
A booster vaccine of the pentavalent diphtheria-tetanus toxoids-acellular pertussis, inactivated polio vaccine and Haemophilus influenzae type b polysaccharide vaccine (Pentaxim, Sanofi-Pasteur) seems to be well tolerated after priming with an investigational hexavalent DTaP-IPV-Hib-PRP-T vaccine (Hexaxim, Sanofi-Pasteur), according to results published online.
Marcelo Tregnaghi, MD, of the Centro de Desarrollo de Proyectos Avanzados, in Córdoba, Argentina, and colleagues conducted an open-label study at the Hospital Materno Neonatal, in Argentina, where they looked at 232 infants previously primed with three doses of Hexaxim or 226 primed with Pentaxim and the Engerix-B Pediatric (GlaxoSmithKline) hepatitis B vaccine at 2, 4 and 6 months of age. The groups received a booster dose of Pentaxim at 18 months.
The study took place from February to November 2006. “Post-booster seroprotection and seroconversion rates were high and similar in each group, and geometric mean antibody concentrations increased markedly in both groups,” Tregnaghi and colleagues said.
Some differences were found in antibodies for hepatitis B, which showed an edge for the Pentaxim-primed and standalone hepatitis B vaccine group at 99.5% compared with 85.5%. The researchers said one convulsion appeared to be vaccine-related, although safety was overall “considered good.”
“Only three unsolicited adverse events were considered by the investigator to be related to the booster vaccine — injection-site hemorrhage, injection-site induration and severe systemic convulsions, the latter also being reported as a serious adverse event. Overall, 23.8% of participants experienced an unsolicited adverse event during the first 30 days after the booster vaccination, with rhinitis and bronchitis being the most frequent,” the researchers said.
Disclosure: One of the study researchers reports being an employee of Sanofi-Aventis, and the study was funded by Sanofi-Pasteur.
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I agree with the authors that this study confirms the suitability of administering the pentavalent vaccine for the toddler dose after administering either the hexavalent or pentavalent vaccine in the primary series. I think there is good priming in each of the study groups, and the safety profile appears similar.
This study suggests that the future use of this investigational vaccine might be helpful in maximizing our immunization rates. Given the number of injections children are given in their first 2 years of life, it is impressive that it may soon be possible to protect children against multiple diseases with even less injections. Knowing that you are able to safely give all of those antigens as a single injection is positive news for parents and providers. When immunization rates are optimized, then that should translate into many fewer vaccine-preventable diseases.
Ongoing studies will hopefully better document the modest difference in response with the hepatitis B antigen included in the hexavalent vaccine. There is less of a concern about hepatitis B, because although it the measured levels appear slightly lower, it does not necessarily indicate that there is a lack of protection. Previous studies have suggested that although anti-hepatitis B surface antigen concentrations decrease over time, patients still respond quite nicely if they are exposed.
Henry H. Bernstein, DO
Infectious Diseases
in Children Editorial Board
Disclosure: Dr. Bernstein reports no relevant financial disclosures.
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