A randomized Phase I/II study to evaluate safety and reactogenicity of a heat-stable rotavirus vaccine in healthy adults followed by evaluation of the safety, reactogenicity, and immunogenicity in infants
Objectives: To assess the safety and reactogenicity of single oral dose of heat-stable rotavirus vaccine (HSRV) in healthy adults aged 18–45 years followed by assessment of safety, reactogenicity, and immunogenicity of three doses of HSRV in healthy infants aged 6–8 weeks at enrollment. Trial Design...
| Main Authors: | , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Taylor & Francis Group
2020-03-01
|
| Series: | Human Vaccines & Immunotherapeutics |
| Subjects: | |
| Online Access: | http://dx.doi.org/10.1080/21645515.2019.1664239 |
| _version_ | 1827809642558783488 |
|---|---|
| author | Vibhu Kanchan Khalequ Zaman Asma Binte Aziz Sheikh Farzana Zaman Farzana Zaman Warda Haque Mahbuba Khanam Mohammad Mahbubul Karim Sachin Kale Syed Khalid Ali Michelle G. Goveia Susan S. Kaplan Davinder Gill Wasif Ali Khan Mohammad Yunus Ajitpal Singh John D. Clemens |
| author_facet | Vibhu Kanchan Khalequ Zaman Asma Binte Aziz Sheikh Farzana Zaman Farzana Zaman Warda Haque Mahbuba Khanam Mohammad Mahbubul Karim Sachin Kale Syed Khalid Ali Michelle G. Goveia Susan S. Kaplan Davinder Gill Wasif Ali Khan Mohammad Yunus Ajitpal Singh John D. Clemens |
| author_sort | Vibhu Kanchan |
| collection | DOAJ |
| description | Objectives: To assess the safety and reactogenicity of single oral dose of heat-stable rotavirus vaccine (HSRV) in healthy adults aged 18–45 years followed by assessment of safety, reactogenicity, and immunogenicity of three doses of HSRV in healthy infants aged 6–8 weeks at enrollment. Trial Design: Single-center randomized controlled, sequential, blinded (adults) and open-label (infants). Setting: Single site at International Center for Diarrheal Disease Research, Bangladesh (icddr,b). Participants: Fifty eligible adults randomized in 1:1 ratio (HSRV: Placebo) followed by 50 eligible infants randomized in 1:1 ratio (HSRV: Comparator (RotaTeq®, pentavalent human-bovine (WC3) reassortant live-attenuated, rotavirus vaccine)). Intervention: Adults received either a single dose of HSRV or placebo and followed for 14 days. Infants received three doses of either HSRV or comparator with a follow-up for 28 days after each dose. Main Outcome Measures: Solicited and unsolicited adverse events (AEs) along with any serious adverse events (SAEs) were part of the safety and reactogenicity assessment in adults and infants whereas serum anti-rotavirus IgA response rates were part of immunogenicity assessment in infants only. Post-vaccination fecal shedding of vaccine-virus rotavirus strains was also determined in adults and infants. Results: In this study, HSRV, when compared with placebo, did not result in increase in solicited adverse events (solicited AEs) in adults. In infants, HSRV had a safety profile similar to comparator vis-à-vis solicited AEs. In infants, fecal shedding of vaccine-virus strains was not detected in HSRV recipients but was observed in two comparator recipients. Percentage of infants exhibiting threefold rise in serum anti-rotavirus IgA titers from baseline to 1-month post-dose 3 in HSRV group was 88% (22/25) and 84% (21/25) in comparator group. Conclusion: HSRV was found to be generally well-tolerated in both adults and infants and immunogenic in infants. |
| first_indexed | 2024-03-11T22:43:22Z |
| format | Article |
| id | doaj.art-05badda615cb4df2864a2b56c7dbf544 |
| institution | Directory Open Access Journal |
| issn | 2164-5515 2164-554X |
| language | English |
| last_indexed | 2024-03-11T22:43:22Z |
| publishDate | 2020-03-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj.art-05badda615cb4df2864a2b56c7dbf5442023-09-22T08:45:33ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2020-03-0116369370210.1080/21645515.2019.16642391664239A randomized Phase I/II study to evaluate safety and reactogenicity of a heat-stable rotavirus vaccine in healthy adults followed by evaluation of the safety, reactogenicity, and immunogenicity in infantsVibhu Kanchan0Khalequ Zaman1Asma Binte Aziz2Sheikh Farzana Zaman3Farzana Zaman4Warda Haque5Mahbuba Khanam6Mohammad Mahbubul Karim7Sachin Kale8Syed Khalid Ali9Michelle G. Goveia10Susan S. Kaplan11Davinder Gill12Wasif Ali Khan13Mohammad Yunus14Ajitpal Singh15John D. Clemens16MSD Wellcome Trust Hilleman Laboratories Pvt. Ltd.icddricddricddricddricddricddricddrMSD Wellcome Trust Hilleman Laboratories Pvt. Ltd.MSD Wellcome Trust Hilleman Laboratories Pvt. Ltd.Merck & Co., IncMerck & Co., IncMSD Wellcome Trust Hilleman Laboratories Pvt. Ltd.icddricddrMSD Wellcome Trust Hilleman Laboratories Pvt. Ltd.icddrObjectives: To assess the safety and reactogenicity of single oral dose of heat-stable rotavirus vaccine (HSRV) in healthy adults aged 18–45 years followed by assessment of safety, reactogenicity, and immunogenicity of three doses of HSRV in healthy infants aged 6–8 weeks at enrollment. Trial Design: Single-center randomized controlled, sequential, blinded (adults) and open-label (infants). Setting: Single site at International Center for Diarrheal Disease Research, Bangladesh (icddr,b). Participants: Fifty eligible adults randomized in 1:1 ratio (HSRV: Placebo) followed by 50 eligible infants randomized in 1:1 ratio (HSRV: Comparator (RotaTeq®, pentavalent human-bovine (WC3) reassortant live-attenuated, rotavirus vaccine)). Intervention: Adults received either a single dose of HSRV or placebo and followed for 14 days. Infants received three doses of either HSRV or comparator with a follow-up for 28 days after each dose. Main Outcome Measures: Solicited and unsolicited adverse events (AEs) along with any serious adverse events (SAEs) were part of the safety and reactogenicity assessment in adults and infants whereas serum anti-rotavirus IgA response rates were part of immunogenicity assessment in infants only. Post-vaccination fecal shedding of vaccine-virus rotavirus strains was also determined in adults and infants. Results: In this study, HSRV, when compared with placebo, did not result in increase in solicited adverse events (solicited AEs) in adults. In infants, HSRV had a safety profile similar to comparator vis-à-vis solicited AEs. In infants, fecal shedding of vaccine-virus strains was not detected in HSRV recipients but was observed in two comparator recipients. Percentage of infants exhibiting threefold rise in serum anti-rotavirus IgA titers from baseline to 1-month post-dose 3 in HSRV group was 88% (22/25) and 84% (21/25) in comparator group. Conclusion: HSRV was found to be generally well-tolerated in both adults and infants and immunogenic in infants.http://dx.doi.org/10.1080/21645515.2019.1664239heat stable rotavirus vaccinerandomizedsafetyreactogenicityimmunogenicity |
| spellingShingle | Vibhu Kanchan Khalequ Zaman Asma Binte Aziz Sheikh Farzana Zaman Farzana Zaman Warda Haque Mahbuba Khanam Mohammad Mahbubul Karim Sachin Kale Syed Khalid Ali Michelle G. Goveia Susan S. Kaplan Davinder Gill Wasif Ali Khan Mohammad Yunus Ajitpal Singh John D. Clemens A randomized Phase I/II study to evaluate safety and reactogenicity of a heat-stable rotavirus vaccine in healthy adults followed by evaluation of the safety, reactogenicity, and immunogenicity in infants Human Vaccines & Immunotherapeutics heat stable rotavirus vaccine randomized safety reactogenicity immunogenicity |
| title | A randomized Phase I/II study to evaluate safety and reactogenicity of a heat-stable rotavirus vaccine in healthy adults followed by evaluation of the safety, reactogenicity, and immunogenicity in infants |
| title_full | A randomized Phase I/II study to evaluate safety and reactogenicity of a heat-stable rotavirus vaccine in healthy adults followed by evaluation of the safety, reactogenicity, and immunogenicity in infants |
| title_fullStr | A randomized Phase I/II study to evaluate safety and reactogenicity of a heat-stable rotavirus vaccine in healthy adults followed by evaluation of the safety, reactogenicity, and immunogenicity in infants |
| title_full_unstemmed | A randomized Phase I/II study to evaluate safety and reactogenicity of a heat-stable rotavirus vaccine in healthy adults followed by evaluation of the safety, reactogenicity, and immunogenicity in infants |
| title_short | A randomized Phase I/II study to evaluate safety and reactogenicity of a heat-stable rotavirus vaccine in healthy adults followed by evaluation of the safety, reactogenicity, and immunogenicity in infants |
| title_sort | randomized phase i ii study to evaluate safety and reactogenicity of a heat stable rotavirus vaccine in healthy adults followed by evaluation of the safety reactogenicity and immunogenicity in infants |
| topic | heat stable rotavirus vaccine randomized safety reactogenicity immunogenicity |
| url | http://dx.doi.org/10.1080/21645515.2019.1664239 |
| work_keys_str_mv | AT vibhukanchan arandomizedphaseiiistudytoevaluatesafetyandreactogenicityofaheatstablerotavirusvaccineinhealthyadultsfollowedbyevaluationofthesafetyreactogenicityandimmunogenicityininfants AT khalequzaman arandomizedphaseiiistudytoevaluatesafetyandreactogenicityofaheatstablerotavirusvaccineinhealthyadultsfollowedbyevaluationofthesafetyreactogenicityandimmunogenicityininfants AT asmabinteaziz arandomizedphaseiiistudytoevaluatesafetyandreactogenicityofaheatstablerotavirusvaccineinhealthyadultsfollowedbyevaluationofthesafetyreactogenicityandimmunogenicityininfants AT sheikhfarzanazaman arandomizedphaseiiistudytoevaluatesafetyandreactogenicityofaheatstablerotavirusvaccineinhealthyadultsfollowedbyevaluationofthesafetyreactogenicityandimmunogenicityininfants AT farzanazaman arandomizedphaseiiistudytoevaluatesafetyandreactogenicityofaheatstablerotavirusvaccineinhealthyadultsfollowedbyevaluationofthesafetyreactogenicityandimmunogenicityininfants AT wardahaque arandomizedphaseiiistudytoevaluatesafetyandreactogenicityofaheatstablerotavirusvaccineinhealthyadultsfollowedbyevaluationofthesafetyreactogenicityandimmunogenicityininfants AT mahbubakhanam arandomizedphaseiiistudytoevaluatesafetyandreactogenicityofaheatstablerotavirusvaccineinhealthyadultsfollowedbyevaluationofthesafetyreactogenicityandimmunogenicityininfants AT mohammadmahbubulkarim arandomizedphaseiiistudytoevaluatesafetyandreactogenicityofaheatstablerotavirusvaccineinhealthyadultsfollowedbyevaluationofthesafetyreactogenicityandimmunogenicityininfants AT sachinkale arandomizedphaseiiistudytoevaluatesafetyandreactogenicityofaheatstablerotavirusvaccineinhealthyadultsfollowedbyevaluationofthesafetyreactogenicityandimmunogenicityininfants AT syedkhalidali arandomizedphaseiiistudytoevaluatesafetyandreactogenicityofaheatstablerotavirusvaccineinhealthyadultsfollowedbyevaluationofthesafetyreactogenicityandimmunogenicityininfants AT michelleggoveia arandomizedphaseiiistudytoevaluatesafetyandreactogenicityofaheatstablerotavirusvaccineinhealthyadultsfollowedbyevaluationofthesafetyreactogenicityandimmunogenicityininfants AT susanskaplan arandomizedphaseiiistudytoevaluatesafetyandreactogenicityofaheatstablerotavirusvaccineinhealthyadultsfollowedbyevaluationofthesafetyreactogenicityandimmunogenicityininfants AT davindergill arandomizedphaseiiistudytoevaluatesafetyandreactogenicityofaheatstablerotavirusvaccineinhealthyadultsfollowedbyevaluationofthesafetyreactogenicityandimmunogenicityininfants AT wasifalikhan arandomizedphaseiiistudytoevaluatesafetyandreactogenicityofaheatstablerotavirusvaccineinhealthyadultsfollowedbyevaluationofthesafetyreactogenicityandimmunogenicityininfants AT mohammadyunus arandomizedphaseiiistudytoevaluatesafetyandreactogenicityofaheatstablerotavirusvaccineinhealthyadultsfollowedbyevaluationofthesafetyreactogenicityandimmunogenicityininfants AT ajitpalsingh arandomizedphaseiiistudytoevaluatesafetyandreactogenicityofaheatstablerotavirusvaccineinhealthyadultsfollowedbyevaluationofthesafetyreactogenicityandimmunogenicityininfants AT johndclemens arandomizedphaseiiistudytoevaluatesafetyandreactogenicityofaheatstablerotavirusvaccineinhealthyadultsfollowedbyevaluationofthesafetyreactogenicityandimmunogenicityininfants AT vibhukanchan randomizedphaseiiistudytoevaluatesafetyandreactogenicityofaheatstablerotavirusvaccineinhealthyadultsfollowedbyevaluationofthesafetyreactogenicityandimmunogenicityininfants AT khalequzaman randomizedphaseiiistudytoevaluatesafetyandreactogenicityofaheatstablerotavirusvaccineinhealthyadultsfollowedbyevaluationofthesafetyreactogenicityandimmunogenicityininfants AT asmabinteaziz randomizedphaseiiistudytoevaluatesafetyandreactogenicityofaheatstablerotavirusvaccineinhealthyadultsfollowedbyevaluationofthesafetyreactogenicityandimmunogenicityininfants AT sheikhfarzanazaman randomizedphaseiiistudytoevaluatesafetyandreactogenicityofaheatstablerotavirusvaccineinhealthyadultsfollowedbyevaluationofthesafetyreactogenicityandimmunogenicityininfants AT farzanazaman randomizedphaseiiistudytoevaluatesafetyandreactogenicityofaheatstablerotavirusvaccineinhealthyadultsfollowedbyevaluationofthesafetyreactogenicityandimmunogenicityininfants AT wardahaque randomizedphaseiiistudytoevaluatesafetyandreactogenicityofaheatstablerotavirusvaccineinhealthyadultsfollowedbyevaluationofthesafetyreactogenicityandimmunogenicityininfants AT mahbubakhanam randomizedphaseiiistudytoevaluatesafetyandreactogenicityofaheatstablerotavirusvaccineinhealthyadultsfollowedbyevaluationofthesafetyreactogenicityandimmunogenicityininfants AT mohammadmahbubulkarim randomizedphaseiiistudytoevaluatesafetyandreactogenicityofaheatstablerotavirusvaccineinhealthyadultsfollowedbyevaluationofthesafetyreactogenicityandimmunogenicityininfants AT sachinkale randomizedphaseiiistudytoevaluatesafetyandreactogenicityofaheatstablerotavirusvaccineinhealthyadultsfollowedbyevaluationofthesafetyreactogenicityandimmunogenicityininfants AT syedkhalidali randomizedphaseiiistudytoevaluatesafetyandreactogenicityofaheatstablerotavirusvaccineinhealthyadultsfollowedbyevaluationofthesafetyreactogenicityandimmunogenicityininfants AT michelleggoveia randomizedphaseiiistudytoevaluatesafetyandreactogenicityofaheatstablerotavirusvaccineinhealthyadultsfollowedbyevaluationofthesafetyreactogenicityandimmunogenicityininfants AT susanskaplan randomizedphaseiiistudytoevaluatesafetyandreactogenicityofaheatstablerotavirusvaccineinhealthyadultsfollowedbyevaluationofthesafetyreactogenicityandimmunogenicityininfants AT davindergill randomizedphaseiiistudytoevaluatesafetyandreactogenicityofaheatstablerotavirusvaccineinhealthyadultsfollowedbyevaluationofthesafetyreactogenicityandimmunogenicityininfants AT wasifalikhan randomizedphaseiiistudytoevaluatesafetyandreactogenicityofaheatstablerotavirusvaccineinhealthyadultsfollowedbyevaluationofthesafetyreactogenicityandimmunogenicityininfants AT mohammadyunus randomizedphaseiiistudytoevaluatesafetyandreactogenicityofaheatstablerotavirusvaccineinhealthyadultsfollowedbyevaluationofthesafetyreactogenicityandimmunogenicityininfants AT ajitpalsingh randomizedphaseiiistudytoevaluatesafetyandreactogenicityofaheatstablerotavirusvaccineinhealthyadultsfollowedbyevaluationofthesafetyreactogenicityandimmunogenicityininfants AT johndclemens randomizedphaseiiistudytoevaluatesafetyandreactogenicityofaheatstablerotavirusvaccineinhealthyadultsfollowedbyevaluationofthesafetyreactogenicityandimmunogenicityininfants |