Evidence map›Paper›PMID 35715351›Full record

Trial reportVaccine2022

A Brighton Collaboration standardized template with key considerations for a benefit/risk assessment for an inactivated viral vaccine against Chikungunya virus.

Libia Milena Hernandez, K Sumathy, Sushant Sahastrabuddhe, Jean-Louis Excler, Sonali Kochhar, Emily R Smith, Marc Gurwith, Robert T Chen, Benefit-Risk Assessment of VAccines by TechnolOgy Working Group (BRAVATO, ex-V3SWG)

Open access · hybridAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Vaccine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.2field-weighted citation impact, top 22% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 7 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 4 institutions in 3 countries.

Libia Milena HernandezInternational Vaccine Institute (IVI), Seoul, Republic of Korea.
K SumathyBharat Biotech International Limited (BBIL), Hyderabad, Telangana, India.
Sushant SahastrabuddheInternational Vaccine Institute (IVI), Seoul, Republic of Korea.
Jean-Louis ExclerInternational Vaccine Institute (IVI), Seoul, Republic of Korea.
Sonali KochharGlobal Healthcare Consulting, New Delhi, India; University of Washington, Seattle, USA.
Emily R SmithBrighton Collaboration, A Program of the Task Force for Global Health, Decatur, GA, USA. Electronic address: bc-coordinator@taskforce.org.
Marc GurwithBrighton Collaboration, A Program of the Task Force for Global Health, Decatur, GA, USA.
Robert T ChenBrighton Collaboration, A Program of the Task Force for Global Health, Decatur, GA, USA.
Benefit-Risk Assessment of VAccines by TechnolOgy Working Group (BRAVATO, ex-V3SWG)
International Vaccine Institute · KRThe Task Force for Global Health · USBharat Biotech (India) · INUniversity of Washington · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Inactivated viral vaccines have long been used in humans for diseases of global health threat (e.g., poliomyelitis and pandemic and seasonal influenza) and the technology of inactivation has more recently been used for emerging diseases such as West Nile, Chikungunya, Ross River, SARS and especially for COVID-19. The Brighton Collaboration Benefit-Risk Assessment of VAccines by TechnolOgy (BRAVATO) Working Group has prepared standardized templates to describe the key considerations for the benefit and risk of several vaccine platform technologies, including inactivated viral vaccines. This paper uses the BRAVATO inactivated virus vaccine template to review the features of an inactivated whole chikungunya virus (CHIKV) vaccine that has been evaluated in several preclinical studies and clinical trials. The inactivated whole CHIKV vaccine was cultured on Vero cells and inactivated by ß-propiolactone. This provides an effective, flexible system for high-yield manufacturing. The inactivated whole CHIKV vaccine has favorable thermostability profiles, compatible with vaccine supply chains. Safety data are compiled in the current inactivated whole CHIKV vaccine safety database with unblinded data from the ongoing studies: 850 participants from phase II study (parts A and B) outside of India, and 600 participants from ongoing phase II study in India, and completed phase I clinical studies for 60 subjects. Overall, the inactivated whole CHIKV vaccine has been well tolerated, with no significant safety issues identified. Evaluation of the inactivated whole CHIKV vaccine is continuing, with 1410 participants vaccinated as of 20 April 2022. Extensive evaluation of immunogenicity in humans shows strong, durable humoral immune responses.

Indexed as

Chikungunya FeverChikungunya virusCOVID-19Viral VaccinesAnimalsAntibodies, ViralChlorocebus aethiopsHumansRisk AssessmentVaccines, InactivatedVero CellsAntibodies, ViralVaccines, InactivatedViral VaccinesBenefit/RiskChikungunyaInactivatedSafetyVaccine

Identifiers

PMID35715351
PMCPMC9197579
OpenAlexW4282913684

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.