A phase I clinical study to assess safety and immunogenicity of yellow fever vaccine
Abstract Yellow fever, a mosquito-borne flavivirus infection, is an important public health problem in Africa and Latin America. A Yellow Fever vaccine (YFV) was developed and tested in a study in India. This was a Phase I, open-label, randomized, controlled study where healthy adults received SII Y...
| Main Authors: | , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Nature Portfolio
2022-12-01
|
| Series: | npj Vaccines |
| Online Access: | https://doi.org/10.1038/s41541-022-00595-6 |
| _version_ | 1797422436822548480 |
|---|---|
| author | Sajjad Desai K. Anil Anirudha Vyankatesh Potey Y. Sindhu Silvia Grappi Giulia Lapini Satyaprasad Manney Parikshit Tyagi Emanuele Montomoli Cyrus S. Poonawalla Prasad S. Kulkarni |
| author_facet | Sajjad Desai K. Anil Anirudha Vyankatesh Potey Y. Sindhu Silvia Grappi Giulia Lapini Satyaprasad Manney Parikshit Tyagi Emanuele Montomoli Cyrus S. Poonawalla Prasad S. Kulkarni |
| author_sort | Sajjad Desai |
| collection | DOAJ |
| description | Abstract Yellow fever, a mosquito-borne flavivirus infection, is an important public health problem in Africa and Latin America. A Yellow Fever vaccine (YFV) was developed and tested in a study in India. This was a Phase I, open-label, randomized, controlled study where healthy adults received SII YFV intramuscularly (SII YFV IM), SII YFV subcutaneously (SII YFV SC) or STAMARIL® (Sanofi-Pasteur) in 1:1:1 ratio. They were followed for solicited reactions for 10 days and unsolicited events for 28 days and serious adverse events for 3 months. YF-neutralizing antibodies were measured at baseline and on Days 10, 14, 28. A total of 60 adults were enrolled in the study. The proportion of participants with solicited reactions was 10%, 40%, and 25% in SII YFV SC, SII YFV IM, and STAMARIL® arms, respectively. No causally related unsolicited events or any serious adverse event was reported. After vaccination, the seroconversion was 94.44%, 100%, and 100%, in the three arms respectively. The post-vaccination geometric mean titers were similar in the study arms. The new YFV was found safe and immunogenic by IM as well as SC routes. The vaccine can be tested in further phases of clinical studies. |
| first_indexed | 2024-03-09T07:32:16Z |
| format | Article |
| id | doaj.art-71efdbde43384da99e64a1d94508dcea |
| institution | Directory Open Access Journal |
| issn | 2059-0105 |
| language | English |
| last_indexed | 2024-03-09T07:32:16Z |
| publishDate | 2022-12-01 |
| publisher | Nature Portfolio |
| record_format | Article |
| series | npj Vaccines |
| spelling | doaj.art-71efdbde43384da99e64a1d94508dcea2023-12-03T05:53:42ZengNature Portfolionpj Vaccines2059-01052022-12-01711610.1038/s41541-022-00595-6A phase I clinical study to assess safety and immunogenicity of yellow fever vaccineSajjad Desai0K. Anil1Anirudha Vyankatesh Potey2Y. Sindhu3Silvia Grappi4Giulia Lapini5Satyaprasad Manney6Parikshit Tyagi7Emanuele Montomoli8Cyrus S. Poonawalla9Prasad S. Kulkarni10Serum Institute of India Pvt LtdSyngene InternationalSerum Institute of India Pvt LtdSyngene InternationalVisMederi SrlVisMederi SrlSerum Institute of India Pvt LtdSerum Institute of India Pvt LtdVisMederi SrlSerum Institute of India Pvt LtdSerum Institute of India Pvt LtdAbstract Yellow fever, a mosquito-borne flavivirus infection, is an important public health problem in Africa and Latin America. A Yellow Fever vaccine (YFV) was developed and tested in a study in India. This was a Phase I, open-label, randomized, controlled study where healthy adults received SII YFV intramuscularly (SII YFV IM), SII YFV subcutaneously (SII YFV SC) or STAMARIL® (Sanofi-Pasteur) in 1:1:1 ratio. They were followed for solicited reactions for 10 days and unsolicited events for 28 days and serious adverse events for 3 months. YF-neutralizing antibodies were measured at baseline and on Days 10, 14, 28. A total of 60 adults were enrolled in the study. The proportion of participants with solicited reactions was 10%, 40%, and 25% in SII YFV SC, SII YFV IM, and STAMARIL® arms, respectively. No causally related unsolicited events or any serious adverse event was reported. After vaccination, the seroconversion was 94.44%, 100%, and 100%, in the three arms respectively. The post-vaccination geometric mean titers were similar in the study arms. The new YFV was found safe and immunogenic by IM as well as SC routes. The vaccine can be tested in further phases of clinical studies.https://doi.org/10.1038/s41541-022-00595-6 |
| spellingShingle | Sajjad Desai K. Anil Anirudha Vyankatesh Potey Y. Sindhu Silvia Grappi Giulia Lapini Satyaprasad Manney Parikshit Tyagi Emanuele Montomoli Cyrus S. Poonawalla Prasad S. Kulkarni A phase I clinical study to assess safety and immunogenicity of yellow fever vaccine npj Vaccines |
| title | A phase I clinical study to assess safety and immunogenicity of yellow fever vaccine |
| title_full | A phase I clinical study to assess safety and immunogenicity of yellow fever vaccine |
| title_fullStr | A phase I clinical study to assess safety and immunogenicity of yellow fever vaccine |
| title_full_unstemmed | A phase I clinical study to assess safety and immunogenicity of yellow fever vaccine |
| title_short | A phase I clinical study to assess safety and immunogenicity of yellow fever vaccine |
| title_sort | phase i clinical study to assess safety and immunogenicity of yellow fever vaccine |
| url | https://doi.org/10.1038/s41541-022-00595-6 |
| work_keys_str_mv | AT sajjaddesai aphaseiclinicalstudytoassesssafetyandimmunogenicityofyellowfevervaccine AT kanil aphaseiclinicalstudytoassesssafetyandimmunogenicityofyellowfevervaccine AT anirudhavyankateshpotey aphaseiclinicalstudytoassesssafetyandimmunogenicityofyellowfevervaccine AT ysindhu aphaseiclinicalstudytoassesssafetyandimmunogenicityofyellowfevervaccine AT silviagrappi aphaseiclinicalstudytoassesssafetyandimmunogenicityofyellowfevervaccine AT giulialapini aphaseiclinicalstudytoassesssafetyandimmunogenicityofyellowfevervaccine AT satyaprasadmanney aphaseiclinicalstudytoassesssafetyandimmunogenicityofyellowfevervaccine AT parikshittyagi aphaseiclinicalstudytoassesssafetyandimmunogenicityofyellowfevervaccine AT emanuelemontomoli aphaseiclinicalstudytoassesssafetyandimmunogenicityofyellowfevervaccine AT cyrusspoonawalla aphaseiclinicalstudytoassesssafetyandimmunogenicityofyellowfevervaccine AT prasadskulkarni aphaseiclinicalstudytoassesssafetyandimmunogenicityofyellowfevervaccine AT sajjaddesai phaseiclinicalstudytoassesssafetyandimmunogenicityofyellowfevervaccine AT kanil phaseiclinicalstudytoassesssafetyandimmunogenicityofyellowfevervaccine AT anirudhavyankateshpotey phaseiclinicalstudytoassesssafetyandimmunogenicityofyellowfevervaccine AT ysindhu phaseiclinicalstudytoassesssafetyandimmunogenicityofyellowfevervaccine AT silviagrappi phaseiclinicalstudytoassesssafetyandimmunogenicityofyellowfevervaccine AT giulialapini phaseiclinicalstudytoassesssafetyandimmunogenicityofyellowfevervaccine AT satyaprasadmanney phaseiclinicalstudytoassesssafetyandimmunogenicityofyellowfevervaccine AT parikshittyagi phaseiclinicalstudytoassesssafetyandimmunogenicityofyellowfevervaccine AT emanuelemontomoli phaseiclinicalstudytoassesssafetyandimmunogenicityofyellowfevervaccine AT cyrusspoonawalla phaseiclinicalstudytoassesssafetyandimmunogenicityofyellowfevervaccine AT prasadskulkarni phaseiclinicalstudytoassesssafetyandimmunogenicityofyellowfevervaccine |