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SARS-CoV-2 Vaccine Clinical Trials Using ACTIV-Informed Harmonized Protocols

ACTIV advised on the protocol designs and endpoints to ensure a harmonized approach across multiple vaccine efficacy trials. The protocol enables analyses of correlates of protection across several vaccine trials being implemented under The Operation (formerly known as Operation Warp Speed) and activated at sites that are part of the NIH COVID-19 Prevention Network.

As vaccine clinical trials using these harmonized protocols are launched, NIH will list those studies on this page.

SARS-CoV-2 Vaccine Clinical Trials Using

Harmonized Protocols Informed by ACTIV

photo of a doctor giving an injection to a patient

Agent	Trial Phase	Description	More Information
Adjuvanted recombinant protein-based vaccine	Phase 1/2	Co-developed by Sanofi and GlaxoSmithKline, this vaccine uses a recombinant protein-based technology. Participants will receive either a single intramuscular injection or two injections 21 days apart.The study expects to enroll 440 participants.	Clinical Trial Record
AZD1222	Phase 3	Developed by Oxford University’s Jenner Institute and Oxford Vaccine Group, and licensed to AstraZeneca for further development, this vaccine uses a non-replicating adenovirus delivery system. Participants will receive two intramuscular injections approximately 4 weeks apart. The study expects to enroll about 30,000 volunteers.	Clinical Trial Record News Release on Trial Launch Statement on Trial Results
JNJ-78436725 (Ad.26.COV2.S)	Phase 3	Developed by Janssen Pharmaceutical Companies of Johnson & Johnson, this vaccine uses a non-replicating adenovirus delivery system. Participants will receive a single intramuscular injection. The study expects to enroll up to 60,000 volunteers.	Clinical Trial Record News Release on Trial Launch News Release on Interim Results Statement on FDA Emergency Use Authorization
mRNA-1273.351	Phase 1	Developed by Moderna, Inc., this vaccine uses the messenger RNA delivery platform and is designed to protect against the B.1.351 SARS-CoV-2 variant. Participants will receive varying dosages. The study expects to enroll 60 volunteers who already have received the mRNA-1273 vaccine and 150 volunteers who have not received any COVID-19 vaccine.	Clinical Trial Record News Release on Trial Launch
mRNA-1273	Phase 3	Co-developed by Moderna, Inc., and NIAID, this vaccine uses the messenger RNA delivery platform. Participants will receive two intramuscular injections 28 days apart. The study expects to enroll about 30,000 volunteers.	Clinical Trial Record News Release on Trial Launch News Release on Interim Results Statement on FDA Emergency Use Authorization
NVX-CoV2373	Phase 3	Developed by Novavax, Inc., this protein subunit vaccine was made using recombinant nanoparticle technology. Participants will receive two intramuscular injections 21 days apart. The study expects to enroll about 30,000 volunteers.	Clinical Trial Record News Release on Trial Launch Statement on Trial Results Statement on CDC Recommendation

This page last reviewed on July 6, 2023

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