A Study to Evaluate the Immunogenicity and Safety of mRNA-1283 COVID-19 Vaccine Boosters

Study at a glance

From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

A Phase 2A, Randomized, Stratified, Observer-Blind Study to Evaluate the Immunogenicity and Safety of mRNA-1283 Vaccine Boosters for SARS-CoV-2

ClinicalTrials.gov ID

NCT05137236

Acronym / sponsor ID

mRNA-1283-P201

Conditions

SARS-CoV-2

Keywords

mRNA-1273, mRNA-1273 vaccine, SARS-CoV-2, SARS-CoV-2 Vaccine, Coronavirus, Virus Diseases, Messenger RNA, COVID-19

Phase

Phase 2

Study type

Interventional

Recruitment status

Completed

Enrolment

540 participants (actual)

Lead sponsor

ModernaTX, Inc.Industry (pharma, biotech, devices)

Study start

6 Dec 2021 (actual)

Primary completion

23 Mar 2023 (actual)

Study completion

23 Mar 2023 (actual)

First posted

30 Nov 2021 (actual)

Results

Posted 17 Jul 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Prevention

Allocation

Randomised

Intervention model

Parallel groups

Masking

Quadruple blind (participant, care provider, investigator, outcomes assessor)

Number of arms

8

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Parts A and B: Number of Participants With Solicited Local and Solicited Systemic Reactogenicity Adverse Reactions (ARs)

   Time frame: Up to Day 7

   An AR is any adverse event (AE) related to the IP injection. Solicited local ARs included pain at injection site, erythema (redness) at injection site, swelling (hardness) at injection site, localized axillary swelling or tenderness ipsilateral to the injection arm, and groin or underarm swelling or tenderness ipsilateral to the side of injection. Solicited systemic ARs included headache, fatigue, myalgia (muscle aches all over the body), arthralgia (aching in several joints), nausea/vomiting, fever, chills, irritability/crying, sleepiness, and loss of appetite. Note, not all solicited ARs were considered AEs. The Investigator determined if solicited AR was also to be recorded as an AE. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

2. Parts A and B: Number of Participants With Unsolicited AEs

   Time frame: Up to Day 28

   An unsolicited AE was defined as any AE reported by the participant that was not specified as a solicited AR in the protocol or was specified as a solicited AR but started outside the protocol-defined period for reporting solicited ARs. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

3. Parts A and B: Number of Participants With Serious Adverse Events (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal From Study Participation and AEs of Special Interest (AESIs)

   Time frame: Day 1 to Day 366

   SAEs were AEs that resulted in death, were life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, a congenital anomaly or birth defect, or was a medically important event. MAAEs were AEs that lead to an unscheduled visit to a healthcare provider. AESIs were AEs (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program for which ongoing monitoring and immediate notification by the investigator to the Sponsor was required. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

4. Part A: Geometric Mean Titer (GMT) of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Specific Neutralizing Antibody (nAb) Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351

   Time frame: Day 29

   The GMT (50% inhibitory dose [ID50]) of nAb against ancestral SARS-CoV-2 and against SARS-CoV-2 variant B.1.351 are reported.

5. Part A: Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Specific nAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351

   Time frame: Day 29

   The GMFR measures the changes in immunogenicity titers or levels within participants.

6. Part A: Number of Participants With Seroresponse Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351

   Time frame: Day 29

   Seroresponse was defined as an increase of SARS-CoV-2 specific binding antibody (bAb) level or nAb titer to at least 4x lower limit of quantification (LLOQ) if the baseline is below the LLOQ, or a 4-fold or greater rise if pre-booster ≥ LLOQ.

7. Part B: GMT of SARS-CoV-2 Specific nAb Against SARS-CoV-2 Omicron Variant (B.1.1.529)

   Time frame: Day 29

   The GMT (ID50) of nAb against SARS-CoV-2 omicron variant (B.1.1.529) are reported.

8. Part B: GMFR of SARS-CoV-2 Specific nAb Against SARS-CoV-2 Omicron Variant (B.1.1.529)

   Time frame: Day 29

   The GMFR measures the changes in immunogenicity titers or levels within participants.

9. Part B: Number of Participants With Seroresponse Against SARS-CoV-2 Omicron Variant (B.1.1.529)

   Time frame: Day 29

   Seroresponse was defined as an increase of SARS-CoV-2 specific bAb level or nAb titer to at least 4x LLOQ if the baseline is below the LLOQ, or a 4-fold or greater rise if pre-booster ≥ LLOQ.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Derived from this study: PubMed 39792478Chalkias S, Pragalos A, Akinsola A, Berman G, Ampajwala M, Meyer J, Schoch L, Zhou W, Paila YD, Deng W, Feng J, de Windt E, Edwards D, Miller J, Das R. Safety and Immunogenicity of SARS-CoV-2 Spike Receptor-Binding Domain and N-Terminal Domain mRNA Vaccine. J Infect Dis. 2025 Apr 15;231(4):e754-e763. doi: 10.1093/infdis/jiaf022.
• Derived from this study: PubMed 37703353Stewart-Jones GBE, Elbashir SM, Wu K, Lee D, Renzi I, Ying B, Koch M, Sein CE, Choi A, Whitener B, Garcia-Dominguez D, Henry C, Woods A, Ma L, Montes Berrueta D, Avena LE, Quinones J, Falcone S, Hsiao CJ, Scheaffer SM, Thackray LB, White P, Diamond MS, Edwards DK, Carfi A. Domain-based mRNA vaccines encoding spike protein N-terminal and receptor binding domains confer protection against SARS-CoV-2. Sci Transl Med. 2023 Sep 13;15(713):eadf4100. doi: 10.1126/scitranslmed.adf4100. Epub 2023 Sep 13.
• Derived from this study: PubMed 36238717Stewart-Jones GBE, Elbashir SM, Wu K, Lee D, Renzi I, Ying B, Koch M, Sein CE, Choi A, Whitener B, Garcia-Dominguez D, Henry C, Woods A, Ma L, Montes Berrueta D, Avena LE, Quinones J, Falcone S, Hsiao CJ, Scheaffer SM, Thackray LB, White P, Diamond MS, Edwards DK, Carfi A. Development of SARS-CoV-2 mRNA vaccines encoding spike N-terminal and receptor binding domains. bioRxiv [Preprint]. 2022 Oct 7:2022.10.07.511319. doi: 10.1101/2022.10.07.511319.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

17 sites in 1 country: see every site and its status.