Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Jan 3;6(1):e2251974.
doi: 10.1001/jamanetworkopen.2022.51974.

Rapid Development of an Integrated Network Infrastructure to Conduct Phase 3 COVID-19 Vaccine Trials

Alfredo J Mena Lora  1 , Jessica E Long  2 , Yunda Huang  3   4 , Lindsey R Baden  5 , Hana M El Sahly  6   7 , Dean Follmann  8 , Paul Goepfert  9 , Glenda Gray  10   11 , Beatriz Grinsztejn  12 , Karen Kotloff  13 , Nadine Rouphael  14 , Magdelena Sobieszczyk  15 , Stephen R Walsh  5 , Jessica Andriesen  3 , Karan A Shah  4 , Yuanyuan Zhang  4 , Peter Gilbert  16 , Holly Janes  3   17 , Cynthia L Gay  18 , Ann R Falsey  19 , Rebecca L Tripp  3 , Richard L Gorman  20 , Tina Tong  21 , Mary Marovich  21 , Kathleen Neuzil  22 , Lawrence Corey  3   23 , James G Kublin  3   24 ; COVID-19 Prevention Network
Collaborators, Affiliations

Rapid Development of an Integrated Network Infrastructure to Conduct Phase 3 COVID-19 Vaccine Trials

Alfredo J Mena Lora et al. JAMA Netw Open. .

Erratum in

  • Error in Figure.
    [No authors listed] [No authors listed] JAMA Netw Open. 2023 May 1;6(5):e2317317. doi: 10.1001/jamanetworkopen.2023.17317. JAMA Netw Open. 2023. PMID: 37213108 Free PMC article. No abstract available.

Abstract

Importance: The COVID-19 pandemic has caused millions of infections and deaths and resulted in unprecedented international public health social and economic crises. As SARS-CoV-2 spread across the globe and its impact became evident, the development of safe and effective vaccines became a priority. Outlining the processes used to establish and support the conduct of the phase 3 randomized clinical trials that led to the rapid emergency use authorization and approval of several COVID-19 vaccines is of major significance for current and future pandemic response efforts.

Observations: To support the rapid development of vaccines for the US population and the rest of the world, the National Institute of Allergy and Infectious Diseases established the COVID-19 Prevention Network (CoVPN) to assist in the coordination and implementation of phase 3 efficacy trials for COVID-19 vaccine candidates and monoclonal antibodies. By bringing together multiple networks, CoVPN was able to draw on existing clinical and laboratory infrastructure, community partnerships, and research expertise to quickly pivot clinical trial sites to conduct COVID-19 vaccine trials as soon as the investigational products were ready for phase 3 testing. The mission of CoVPN was to operationalize phase 3 vaccine trials using harmonized protocols, laboratory assays, and a single data and safety monitoring board to oversee the various studies. These trials, while staggered in time of initiation, overlapped in time and course of conduct and ultimately led to the successful completion of multiple studies and US Food and Drug Administration-licensed or -authorized vaccines, the first of which was available to the public less than 1 year from the discovery of the virus.

Conclusions and relevance: This Special Communication describes the design, geographic distribution, and underlying principles of conduct of these efficacy trials and summarizes data from 136 382 prospectively followed-up participants, including more than 2500 with documented COVID-19. These successful efforts can be replicated for other important research initiatives and point to the importance of investments in clinical trial infrastructure integral to pandemic preparedness.

PubMed Disclaimer

Figures

Figure 1.
Figure 1.. COVID-19 Prevention Network Studies 3001 to 3005 Analysis-Ready Blinded Phase Data Summary as of November 15, 2021
EUA indicates emergency use authorization.
Figure 2.
Figure 2.. Predominant Circulating COVID-19 Variant Timeline Overlaid With Vaccine Clinical Trials in the US, South Africa, and Brazil
See this image and copyright information in PMC

References

    1. National Institutes of Health. NIH to launch public-private partnership to speed COVID-19 vaccine and treatment options. April 17, 2020. Accessed June 25, 2022. https://www.nih.gov/news-events/news-releases/nih-launch-public-private-...
    1. Collins FS, Stoffels P. Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV): an unprecedented partnership for unprecedented times. JAMA. 2020;323(24):2455–2457. doi:10.1001/jama.2020.8920 - DOI - PubMed
    1. Corey L, Mascola JR, Fauci AS, Collins FS. A strategic approach to COVID-19 vaccine R&D. Science. 2020;368 (6494):948–950. doi:10.1126/science.abc5312 - DOI - PubMed
    1. National Institutes of Health. Testimony on vaccines: saving lives, ensuring confidence, and protecting public health. September 9, 2020. Accessed June 25, 2022. https://www.nih.gov/about-nih/who-we-are/nih-director/testimony-vaccines...
    1. National Institute of Allergy and Infectious Diseases. NIH launches clinical trials network to test COVID-19 vaccines and other prevention tools. July 8, 2020. Accessed June 26, 2022. https://www.niaid.nih.gov/news-events/nih-launches-clinical-trials-netwo...

Publication types