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Safety and immunogenicity of a monovalent MF59®-adjuvanted A/H1N1 vaccine in HIV-infected children and young adults.
Biologicals. 2012 Mar; 40(2):134-9.B

Abstract

BACKGROUND

This Phase IV study evaluated the safety and immunogenicity of a two-dose, MF59®-adjuvanted (Novartis Vaccines, Marburg, Germany), monovalent, A/H1N1 pandemic influenza vaccination schedule in Human Immunodeficiency Virus (HIV) positive children and young adults.

METHODS

A total of 83 children infected with HIV-1, and 37 non-immunocompromised, age-matched controls were enrolled. All participants received two vaccine doses administered three weeks apart. Antibody responses were assessed by haemagglutination assay at baseline, three weeks after each vaccine dose, and six months after immunization. Vaccines were evaluated according to European influenza vaccine licensure criteria.

RESULTS

The investigational vaccine was well tolerated. After the first vaccine dose, seroconversion rates were significantly lower in HIV-positive patients (60%) than controls (82%), with GMTs of 419 and 600, respectively. No significant differences in seroconversion rates were observed between the two study groups in response to the second vaccine dose. Persisting antibody titers were similar for both HIV-positive and non-infected controls, six months after immunization.

CONCLUSION

One dose of MF59-adjuvanted vaccine was sufficient to provide adequate levels of seroprotection against A/H1N1 influenza disease in HIV-positive children. However, a two-dose vaccination schedule may be optimal for this population.

Authors+Show Affiliations

University Department of Pediatrics, DPUO, Clinical Trial Center Unit, Bambino Gesù Children's Hospital, Piazza S, Onofrio 4, 00165 Rome, Italy. paolo.palma@opbg.netNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase IV
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22261282

Citation

Palma, Paolo, et al. "Safety and Immunogenicity of a Monovalent MF59®-adjuvanted A/H1N1 Vaccine in HIV-infected Children and Young Adults." Biologicals : Journal of the International Association of Biological Standardization, vol. 40, no. 2, 2012, pp. 134-9.
Palma P, Romiti ML, Bernardi S, et al. Safety and immunogenicity of a monovalent MF59®-adjuvanted A/H1N1 vaccine in HIV-infected children and young adults. Biologicals. 2012;40(2):134-9.
Palma, P., Romiti, M. L., Bernardi, S., Pontrelli, G., Mora, N., Santilli, V., Tchidjou, H. K., Aquilani, A., Cotugno, N., Alghisi, F., Lucidi, V., Rossi, P., & Douagi, I. (2012). Safety and immunogenicity of a monovalent MF59®-adjuvanted A/H1N1 vaccine in HIV-infected children and young adults. Biologicals : Journal of the International Association of Biological Standardization, 40(2), 134-9. https://doi.org/10.1016/j.biologicals.2011.12.001
Palma P, et al. Safety and Immunogenicity of a Monovalent MF59®-adjuvanted A/H1N1 Vaccine in HIV-infected Children and Young Adults. Biologicals. 2012;40(2):134-9. PubMed PMID: 22261282.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and immunogenicity of a monovalent MF59®-adjuvanted A/H1N1 vaccine in HIV-infected children and young adults. AU - Palma,Paolo, AU - Romiti,Maria Luisa, AU - Bernardi,Stefania, AU - Pontrelli,Giuseppe, AU - Mora,Nadia, AU - Santilli,Veronica, AU - Tchidjou,Hyppolite Kuekou, AU - Aquilani,Angela, AU - Cotugno,Nicola, AU - Alghisi,Federico, AU - Lucidi,Vincenzina, AU - Rossi,Paolo, AU - Douagi,Iyadh, Y1 - 2012/01/20/ PY - 2011/07/29/received PY - 2011/11/26/revised PY - 2011/12/13/accepted PY - 2012/1/21/entrez PY - 2012/1/21/pubmed PY - 2012/7/11/medline SP - 134 EP - 9 JF - Biologicals : journal of the International Association of Biological Standardization JO - Biologicals VL - 40 IS - 2 N2 - BACKGROUND: This Phase IV study evaluated the safety and immunogenicity of a two-dose, MF59®-adjuvanted (Novartis Vaccines, Marburg, Germany), monovalent, A/H1N1 pandemic influenza vaccination schedule in Human Immunodeficiency Virus (HIV) positive children and young adults. METHODS: A total of 83 children infected with HIV-1, and 37 non-immunocompromised, age-matched controls were enrolled. All participants received two vaccine doses administered three weeks apart. Antibody responses were assessed by haemagglutination assay at baseline, three weeks after each vaccine dose, and six months after immunization. Vaccines were evaluated according to European influenza vaccine licensure criteria. RESULTS: The investigational vaccine was well tolerated. After the first vaccine dose, seroconversion rates were significantly lower in HIV-positive patients (60%) than controls (82%), with GMTs of 419 and 600, respectively. No significant differences in seroconversion rates were observed between the two study groups in response to the second vaccine dose. Persisting antibody titers were similar for both HIV-positive and non-infected controls, six months after immunization. CONCLUSION: One dose of MF59-adjuvanted vaccine was sufficient to provide adequate levels of seroprotection against A/H1N1 influenza disease in HIV-positive children. However, a two-dose vaccination schedule may be optimal for this population. SN - 1095-8320 UR - https://www.unboundmedicine.com/medline/citation/22261282/Safety_and_immunogenicity_of_a_monovalent_MF59��_adjuvanted_A/H1N1_vaccine_in_HIV_infected_children_and_young_adults_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1045-1056(11)00193-X DB - PRIME DP - Unbound Medicine ER -