Evidence map›Paper›PMID 37596281›Full record

ArticleNPJ vaccines2023

Phase III Pivotal comparative clinical trial of intranasal (iNCOVACC) and intramuscular COVID 19 vaccine (Covaxin

Chandramani Singh, Savita Verma, Prabhakar Reddy, Michael S Diamond, David T Curiel, Chintan Patel, Manish Kumar Jain, Sagar Vivek Redkar, Amit Suresh Bhate, Vivek Gundappa and 12 more

Registry-linked trialAbstract read
In one paragraph

Article in NPJ vaccines, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05522335 (A Phase III Randomized Open Label Multi-center Study to Compare Immunogenicity and Safety of BBV154 With COVAXIN®, and to Assess Lot to Lot Consistency of BBV154 in Healthy Volunteers), which is not on this map. Cited by 60 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
60citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT05522335 phase3unknown statusnot on this map

A Phase III Randomized Open Label Multi-center Study to Compare Immunogenicity and Safety of BBV154 With COVAXIN®, and to Assess Lot to Lot Consistency of BBV154 in Healthy Volunteers

TypeinterventionalSponsorBharat Biotech International LimitedRan2022 to 2023Enrolled3,160ConditionsCOVID-19 Respiratory InfectionArmsBBV154(Intranasal) & covaxin
3 · Its place in the literature

Who cites it

60 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Mucosal immunity and vaccine development.Signal transduction and targeted therapy · 2026
    Pooled it
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Review
  7. The immunogenicity and safety of adenoviral-based vaccines.Current opinion in allergy and clinical immunology · 2026
    Review
  8. Article
  9. Article
  10. Article
  11. Article
  12. Review
  13. Article
  14. Article
  15. Article
  16. Review
  17. Review
  18. Article
  19. Article
  20. Review
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

22 authors.

Chandramani SinghAll India Institute of Medical Sciences, Patna, Bihar, India.
Savita VermaPt. BD Sharma Postgraduate Institute of Medical Sciences (PGIMS), Rohtak, Haryana, India.
Prabhakar ReddyNizams Institute of Medical Sciences, Hyderabad, Telangana, India.
Michael S DiamondDepartment of Medicine, Molecular Microbiology, Pathology & Immunology, Washington University School of Medicine, St. Louis, MO, USA.ORCID http://orcid.org/0000-0002-8791-3165
David T CurielDepartment of Radiation Oncology, Washington University School of Medicine, St. Louis, MO, USA.ORCID http://orcid.org/0000-0003-3802-6014
Chintan PatelAatman Hospital, Ahmedabad, India.
Manish Kumar JainMaharaja Agrasen Super Speciality Hospital, Jaipur, Rajasthan, India.
Sagar Vivek RedkarRedkar Hospital and Research Centre, Goa, India.
Amit Suresh BhateJeevan Rekha Hospital, Belgaum, Karnataka, India.
Vivek GundappaRajarajeswari Medical College and Hospital, Bangalore, Karnataka, India.ORCID http://orcid.org/0000-0002-3644-3765
Rambabu KonathamVisakha Institute of Medical Science, Visakhapatnam, Andhra Pradesh, India.
Leelabati ToppoMalla Reddy Narayana Multispeciality Hospital, Hyderabad, Telangana, India.
Aniket Chandrakant JoshiOyster and Pearl Hospitals (Phadnis Clinic), Pune, Maharashtra, India.
Jitendra Singh KushwahaPrakhar Hospital, Kanpur, Uttar Pradesh, India.
Ajit Pratap SinghRana Hospital, Gorakhpur, Uttar Pradesh, India.
Shilpa BawankuleAcharya Vinobha Bhave Rural Hospital, Wardha, Maharashtra, India.
Raches EllaBharat Biotech International Limited, Hyderabad, India.
Sai PrasadBharat Biotech International Limited, Hyderabad, India.
Brunda GanneruBharat Biotech International Limited, Hyderabad, India.
Siddharth Reddy ChitetiBharat Biotech International Limited, Hyderabad, India.
Sreenivas KataramBharat Biotech International Limited, Hyderabad, India.
Krishna Mohan VadrevuBharat Biotech International Limited, Hyderabad, India. kmohan@bharatbiotech.com.

Funding

Department of Biotechnology, Ministry of Science and Technology (DBT) BT/CS0019/CS/01/20 Dt.12.04.2021
6 · The paper itself

Abstract

One of the most preferable characteristics for a COVID-19 vaccine candidate is the ability to reduce transmission and infection of SARS-CoV-2, in addition to disease prevention. Unlike intramuscular vaccines, intranasal COVID-19 vaccines may offer this by generating mucosal immunity. In this open-label, randomised, multicentre, phase 3 clinical trial (CTRI/2022/02/40065; ClinicalTrials.gov: NCT05522335), healthy adults were randomised to receive two doses, 28 days apart, of either intranasal adenoviral vectored SARS-CoV-2 vaccine (BBV154) or licensed intramuscular vaccine, Covaxin

Identifiers

PMID37596281
PMCPMC10439197

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.