PMID- 31526218
OWN - NLM
STAT- MEDLINE
DCOM- 20210621
LR  - 20220531
IS  - 2164-554X (Electronic)
IS  - 2164-5515 (Print)
IS  - 2164-5515 (Linking)
VI  - 16
IP  - 3
DP  - 2020 Mar 3
TI  - 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.
PG  - 693-702
LID - 10.1080/21645515.2019.1664239 [doi]
AB  - 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(R), 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-a-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.
FAU - Kanchan, Vibhu
AU  - Kanchan V
AUID- ORCID: 0000-0002-5182-2552
AD  - MSD Wellcome Trust Hilleman Laboratories Pvt. Ltd., New Delhi, India.
FAU - Zaman, Khalequ
AU  - Zaman K
AD  - icddr, Dhaka, Bangladesh.
FAU - Aziz, Asma Binte
AU  - Aziz AB
AD  - icddr, Dhaka, Bangladesh.
FAU - Zaman, Sheikh Farzana
AU  - Zaman SF
AD  - icddr, Dhaka, Bangladesh.
FAU - Zaman, Farzana
AU  - Zaman F
AD  - icddr, Dhaka, Bangladesh.
FAU - Haque, Warda
AU  - Haque W
AUID- ORCID: 0000-0002-5437-6228
AD  - icddr, Dhaka, Bangladesh.
FAU - Khanam, Mahbuba
AU  - Khanam M
AD  - icddr, Dhaka, Bangladesh.
FAU - Karim, Mohammad Mahbubul
AU  - Karim MM
AD  - icddr, Dhaka, Bangladesh.
FAU - Kale, Sachin
AU  - Kale S
AD  - MSD Wellcome Trust Hilleman Laboratories Pvt. Ltd., New Delhi, India.
FAU - Ali, Syed Khalid
AU  - Ali SK
AD  - MSD Wellcome Trust Hilleman Laboratories Pvt. Ltd., New Delhi, India.
FAU - Goveia, Michelle G
AU  - Goveia MG
AD  - Merck & Co., Inc., Kenilworth, NJ, USA.
FAU - Kaplan, Susan S
AU  - Kaplan SS
AD  - Merck & Co., Inc., Kenilworth, NJ, USA.
FAU - Gill, Davinder
AU  - Gill D
AD  - MSD Wellcome Trust Hilleman Laboratories Pvt. Ltd., New Delhi, India.
FAU - Khan, Wasif Ali
AU  - Khan WA
AUID- ORCID: 0000-0002-7650-8068
AD  - icddr, Dhaka, Bangladesh.
FAU - Yunus, Mohammad
AU  - Yunus M
AD  - icddr, Dhaka, Bangladesh.
FAU - Singh, Ajitpal
AU  - Singh A
AUID- ORCID: 0000-0002-1526-6624
AD  - MSD Wellcome Trust Hilleman Laboratories Pvt. Ltd., New Delhi, India.
FAU - Clemens, John D
AU  - Clemens JD
AD  - icddr, Dhaka, Bangladesh.
LA  - eng
SI  - ClinicalTrials.gov/NCT02728869
GR  - WT_/Wellcome Trust/United Kingdom
PT  - Clinical Trial, Phase I
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20191029
PL  - United States
TA  - Hum Vaccin Immunother
JT  - Human vaccines & immunotherapeutics
JID - 101572652
RN  - 0 (Antibodies, Viral)
RN  - 0 (Rotavirus Vaccines)
RN  - 0 (Vaccines, Attenuated)
SB  - IM
MH  - Adult
MH  - Animals
MH  - Antibodies, Viral
MH  - Bangladesh
MH  - Cattle
MH  - Double-Blind Method
MH  - Hot Temperature
MH  - Humans
MH  - Immunogenicity, Vaccine
MH  - Infant
MH  - *Rotavirus
MH  - *Rotavirus Infections/prevention & control
MH  - *Rotavirus Vaccines/adverse effects
MH  - Vaccines, Attenuated/adverse effects
PMC - PMC7227685
OTO - NOTNLM
OT  - Heat stable rotavirus vaccine
OT  - immunogenicity
OT  - randomized
OT  - reactogenicity
OT  - safety
EDAT- 2019/09/19 06:00
MHDA- 2021/06/22 06:00
PMCR- 2019/10/29
CRDT- 2019/09/19 06:00
PHST- 2019/09/19 06:00 [pubmed]
PHST- 2021/06/22 06:00 [medline]
PHST- 2019/09/19 06:00 [entrez]
PHST- 2019/10/29 00:00 [pmc-release]
AID - 1664239 [pii]
AID - 10.1080/21645515.2019.1664239 [doi]
PST - ppublish
SO  - Hum Vaccin Immunother. 2020 Mar 3;16(3):693-702. doi: 
      10.1080/21645515.2019.1664239. Epub 2019 Oct 29.