Tags

Type your tag names separated by a space and hit enter

Safety and immunogenicity of live attenuated influenza reassortant H5 vaccine (phase I-II clinical trials).
Influenza Other Respir Viruses. 2008 Nov; 2(6):203-9.IO

Abstract

OBJECTIVE

Our studies aimed to evaluate in clinical trials the safety and immunogenicity of an H5 live influenza vaccine candidate obtained using classical reassortment techniques from a low pathogenicity avian influenza (LPAI) A/Duck/Potsdam/1402-6/86(H5N2) virus and the cold-adapted (ca) donor strain A/Leningrad/134/17/57(H2N2).

METHODS

During Phase I-II clinical trials, volunteers received intranasally two doses of reassortant influenza vaccine strain A/17/Duck/Potsdam/86/92 (H5N2) 21 days apart. Clinical examination of all vaccinees was conducted 7 days post-vaccination. Serum antibody responses were measured by hemagglutination-inhibition and microneutralization and local antibodies were estimated using an enzyme-linked immunosorbent assay test.

RESULTS

The vaccine was safe and of low reactogenicity with no febrile reactions. After revaccination 47.1-54.8% of subjects showed > or =fourfold seroconversions of Hamagglutination inhibition (HAI) antibodies to the hemagglutinin (HA) antigen of the A/17/Duck/Potsdam/86/92 (H5N2) virus and 29.4-30.8% were seroconverted to the HA antigen of the reverse genetics reassortant A/Indonesia/05/2005 x PR8 IBCDC-RG (H5N1). Virus-neutralizing antibody levels in sera of volunteers were similar to those shown in HAI test. The virus-specific nasal IgA antibody response after two vaccine doses demonstrated significant increases of > or =fourfold rise SIgA antibodies (65%) geometrical mean titers (16.0) and a rise in SIgA antibodies (2.8) compared with one dose.

CONCLUSION

The live attenuated influenza vaccine candidate prepared using the LPAI A(H5N2) strain was well tolerated and elicited serum and local immune responses. There was evident cross-reactivity to the A(H5N1) strain in the HAI test.

Authors+Show Affiliations

Institute of Experimental Medicine, Russian Academy of Medical Sciences, Acad. Pavlov's Street, Saint Petersburg, Russia. vaccine@mail.ruNo 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 I
Clinical Trial, Phase II
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19453396

Citation

Rudenko, Larisa, et al. "Safety and Immunogenicity of Live Attenuated Influenza Reassortant H5 Vaccine (phase I-II Clinical Trials)." Influenza and Other Respiratory Viruses, vol. 2, no. 6, 2008, pp. 203-9.
Rudenko L, Desheva J, Korovkin S, et al. Safety and immunogenicity of live attenuated influenza reassortant H5 vaccine (phase I-II clinical trials). Influenza Other Respir Viruses. 2008;2(6):203-9.
Rudenko, L., Desheva, J., Korovkin, S., Mironov, A., Rekstin, A., Grigorieva, E., Donina, S., Gambaryan, A., & Katlinsky, A. (2008). Safety and immunogenicity of live attenuated influenza reassortant H5 vaccine (phase I-II clinical trials). Influenza and Other Respiratory Viruses, 2(6), 203-9. https://doi.org/10.1111/j.1750-2659.2008.00064.x
Rudenko L, et al. Safety and Immunogenicity of Live Attenuated Influenza Reassortant H5 Vaccine (phase I-II Clinical Trials). Influenza Other Respir Viruses. 2008;2(6):203-9. PubMed PMID: 19453396.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and immunogenicity of live attenuated influenza reassortant H5 vaccine (phase I-II clinical trials). AU - Rudenko,Larisa, AU - Desheva,Julia, AU - Korovkin,Sergey, AU - Mironov,Alexander, AU - Rekstin,Andrey, AU - Grigorieva,Elena, AU - Donina,Svetlana, AU - Gambaryan,Alexandra, AU - Katlinsky,Anton, PY - 2009/5/21/entrez PY - 2009/5/21/pubmed PY - 2009/6/9/medline SP - 203 EP - 9 JF - Influenza and other respiratory viruses JO - Influenza Other Respir Viruses VL - 2 IS - 6 N2 - OBJECTIVE: Our studies aimed to evaluate in clinical trials the safety and immunogenicity of an H5 live influenza vaccine candidate obtained using classical reassortment techniques from a low pathogenicity avian influenza (LPAI) A/Duck/Potsdam/1402-6/86(H5N2) virus and the cold-adapted (ca) donor strain A/Leningrad/134/17/57(H2N2). METHODS: During Phase I-II clinical trials, volunteers received intranasally two doses of reassortant influenza vaccine strain A/17/Duck/Potsdam/86/92 (H5N2) 21 days apart. Clinical examination of all vaccinees was conducted 7 days post-vaccination. Serum antibody responses were measured by hemagglutination-inhibition and microneutralization and local antibodies were estimated using an enzyme-linked immunosorbent assay test. RESULTS: The vaccine was safe and of low reactogenicity with no febrile reactions. After revaccination 47.1-54.8% of subjects showed > or =fourfold seroconversions of Hamagglutination inhibition (HAI) antibodies to the hemagglutinin (HA) antigen of the A/17/Duck/Potsdam/86/92 (H5N2) virus and 29.4-30.8% were seroconverted to the HA antigen of the reverse genetics reassortant A/Indonesia/05/2005 x PR8 IBCDC-RG (H5N1). Virus-neutralizing antibody levels in sera of volunteers were similar to those shown in HAI test. The virus-specific nasal IgA antibody response after two vaccine doses demonstrated significant increases of > or =fourfold rise SIgA antibodies (65%) geometrical mean titers (16.0) and a rise in SIgA antibodies (2.8) compared with one dose. CONCLUSION: The live attenuated influenza vaccine candidate prepared using the LPAI A(H5N2) strain was well tolerated and elicited serum and local immune responses. There was evident cross-reactivity to the A(H5N1) strain in the HAI test. SN - 1750-2659 UR - https://www.unboundmedicine.com/medline/citation/19453396/Safety_and_immunogenicity_of_live_attenuated_influenza_reassortant_H5_vaccine__phase_I_II_clinical_trials__ L2 - https://doi.org/10.1111/j.1750-2659.2008.00064.x DB - PRIME DP - Unbound Medicine ER -