Immunogenicity and safety of a quadrivalent inactivated influenza vaccine in pregnant women: a randomized, observer-blind trial
Vaccination against influenza during pregnancy provides direct protection to pregnant women and indirect protection to their infants. Trivalent inactivated influenza vaccines (IIV3s) are safe and effective during pregnancy, but quadrivalent inactivated influenza vaccines (IIV4s) have not been evalua...
| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2020-03-01
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| Series: | Human Vaccines & Immunotherapeutics |
| Subjects: | |
| Online Access: | http://dx.doi.org/10.1080/21645515.2019.1667202 |
| _version_ | 1827809727521751040 |
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| author | Timo Vesikari Miia Virta Seppo Heinonen Cécile Eymin Nathalie Lavis Anne Laure Chabanon Viviane Gresset-Bourgeois |
| author_facet | Timo Vesikari Miia Virta Seppo Heinonen Cécile Eymin Nathalie Lavis Anne Laure Chabanon Viviane Gresset-Bourgeois |
| author_sort | Timo Vesikari |
| collection | DOAJ |
| description | Vaccination against influenza during pregnancy provides direct protection to pregnant women and indirect protection to their infants. Trivalent inactivated influenza vaccines (IIV3s) are safe and effective during pregnancy, but quadrivalent inactivated influenza vaccines (IIV4s) have not been evaluated in pregnant women and their infants. Here, we report the results of a randomized phase IV study to evaluate the immunogenicity and safety of IIV4 vs. IIV3 in pregnant women. Participants aged ≥18 years at weeks 20 to 32 of gestation were randomly assigned in a 2:1 ratio to receive a single dose of IIV4 (n = 230) or IIV3 (n = 116). Between baseline and 21 days after vaccination, hemagglutination inhibition (HAI) antibody titers increased in both groups by similar magnitudes for the two influenza A strains and single B strain common to IIV4 and IIV3. For the additional B strain in IIV4, HAI titers were higher in IIV4 recipients than IIV3 recipients (post-/pre-vaccination geometric mean titer ratio, 6.3 [95% CI: 5.1 − 7.7] vs. 3.4 [95% CI: 2.7 − 4.3]). At delivery, in both groups, HAI antibody titers for all strains were 1.5 − 1.9-fold higher in umbilical cord blood than in maternal blood, confirming active transplacental antibody transfer. Rates of solicited and unsolicited vaccine-related adverse events in mothers were similar between the two groups. Live births were reported for all participants and there were no vaccine-related adverse events in newborns. These results suggest IIV4 is as safe and immunogenic as IIV3 in pregnant women, and that maternal immunization with IIV4 should protect newborns against influenza via passively acquired antibodies. |
| first_indexed | 2024-03-11T22:43:51Z |
| format | Article |
| id | doaj.art-87aeee6b970b48c78279b3d8ddd1936b |
| institution | Directory Open Access Journal |
| issn | 2164-5515 2164-554X |
| language | English |
| last_indexed | 2024-03-11T22:43:51Z |
| publishDate | 2020-03-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj.art-87aeee6b970b48c78279b3d8ddd1936b2023-09-22T08:45:33ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2020-03-0116362362910.1080/21645515.2019.16672021667202Immunogenicity and safety of a quadrivalent inactivated influenza vaccine in pregnant women: a randomized, observer-blind trialTimo Vesikari0Miia Virta1Seppo Heinonen2Cécile Eymin3Nathalie Lavis4Anne Laure Chabanon5Viviane Gresset-Bourgeois6Tampere UniversityTampere UniversityHelsinki University HospitalCampus Sanofi LyonCampus Sanofi LyonSanofi PasteurSanofi PasteurVaccination against influenza during pregnancy provides direct protection to pregnant women and indirect protection to their infants. Trivalent inactivated influenza vaccines (IIV3s) are safe and effective during pregnancy, but quadrivalent inactivated influenza vaccines (IIV4s) have not been evaluated in pregnant women and their infants. Here, we report the results of a randomized phase IV study to evaluate the immunogenicity and safety of IIV4 vs. IIV3 in pregnant women. Participants aged ≥18 years at weeks 20 to 32 of gestation were randomly assigned in a 2:1 ratio to receive a single dose of IIV4 (n = 230) or IIV3 (n = 116). Between baseline and 21 days after vaccination, hemagglutination inhibition (HAI) antibody titers increased in both groups by similar magnitudes for the two influenza A strains and single B strain common to IIV4 and IIV3. For the additional B strain in IIV4, HAI titers were higher in IIV4 recipients than IIV3 recipients (post-/pre-vaccination geometric mean titer ratio, 6.3 [95% CI: 5.1 − 7.7] vs. 3.4 [95% CI: 2.7 − 4.3]). At delivery, in both groups, HAI antibody titers for all strains were 1.5 − 1.9-fold higher in umbilical cord blood than in maternal blood, confirming active transplacental antibody transfer. Rates of solicited and unsolicited vaccine-related adverse events in mothers were similar between the two groups. Live births were reported for all participants and there were no vaccine-related adverse events in newborns. These results suggest IIV4 is as safe and immunogenic as IIV3 in pregnant women, and that maternal immunization with IIV4 should protect newborns against influenza via passively acquired antibodies.http://dx.doi.org/10.1080/21645515.2019.1667202immunizationinfluenza vaccinesnewborn infantpregnancysafetyseasonal influenzatransplacental antibody transfervaccination |
| spellingShingle | Timo Vesikari Miia Virta Seppo Heinonen Cécile Eymin Nathalie Lavis Anne Laure Chabanon Viviane Gresset-Bourgeois Immunogenicity and safety of a quadrivalent inactivated influenza vaccine in pregnant women: a randomized, observer-blind trial Human Vaccines & Immunotherapeutics immunization influenza vaccines newborn infant pregnancy safety seasonal influenza transplacental antibody transfer vaccination |
| title | Immunogenicity and safety of a quadrivalent inactivated influenza vaccine in pregnant women: a randomized, observer-blind trial |
| title_full | Immunogenicity and safety of a quadrivalent inactivated influenza vaccine in pregnant women: a randomized, observer-blind trial |
| title_fullStr | Immunogenicity and safety of a quadrivalent inactivated influenza vaccine in pregnant women: a randomized, observer-blind trial |
| title_full_unstemmed | Immunogenicity and safety of a quadrivalent inactivated influenza vaccine in pregnant women: a randomized, observer-blind trial |
| title_short | Immunogenicity and safety of a quadrivalent inactivated influenza vaccine in pregnant women: a randomized, observer-blind trial |
| title_sort | immunogenicity and safety of a quadrivalent inactivated influenza vaccine in pregnant women a randomized observer blind trial |
| topic | immunization influenza vaccines newborn infant pregnancy safety seasonal influenza transplacental antibody transfer vaccination |
| url | http://dx.doi.org/10.1080/21645515.2019.1667202 |
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