Trial NCT04368988
Publication Mallory R, Lancet Infect Dis, 2022
Dates: 2020-08-24 to 2020-09-25
Funding: Mixed (Novavax and the Coalition for Epidemic Preparedness Innovations (CEPI) )
Conflict of interest: Yes

Methods
RCT
Location : Multicenter / Australia, USA
Follow-up duration (months): 1.15
NVX-CoV2373 primary schedule/NVX-CoV2373 booster (n = 104)
NVX-CoV2373 primary schedule/placebo booster (n = 106)
Placebo primary schedule (n = 173)
Inclusion criteria
  • Healthy male and female participants
  • ≥ 18 to ≤ 84 years of age
  • body mass index of 17 to 35 kg/m2
  • able to provide informed consent prior to enrollment
  • (for female participants) agreed to remain heterosexually inactive or use approved forms of contraception
  • Written informed consent
  • previous receipt of two doses of NVX-CoV2373 (5 μg SARS-CoV-2 rS + 50 μg Matrix-M adjuvant) on Day 0 and Day 21 in part 1 of the trial.
Exclusion criteria
  • History of severe acute respiratory syndrome (SARS) or a confirmed diagnosis of COVID-19
  • serious chronic medical conditions (eg, diabetes mellitus, congestive heart failure, autoimmune conditions, malignancy)
  • currently being assessed for an undiagnosed illness which may lead to a new diagnosis
  • pregnant or breastfeeding females
Interventions
Intervention
1 IM 5 mcg NVX-CoV2373 homologous booster 189 days after 2-dose primary schedule
Control
1 IM dose placebo 189 days after 2-dose NVX-CoV2373 primary schedule1 IM dose placebo 189 days after 2-dose placebo primary schedule
Participants
Randomized
383 participants
Characteristics of participants
Type of participants: Adults
N=383
201 males
Children: 0
Pregnant women: 0
Immunocompromized patients: 0
Mean age:
Age range: 19-82
Description of participants
Healthy adults (stable comorbidities and confirmed COVID-19 with mild symptoms permitted) who had received 2 doses NVX-CoV2373 or placebo in a trial at 17 centers in Australia and USA
Primary outcome
In the register
1) Serum IgG Antibody Levels Expressed as GMEUs - Phase 2 [ Time Frame: Day 35 ]; 2) Serum IgG Antibody Levels Expressed as GMFRs - Phase 2 [ Time Frame: Day 35 ]; 3) Serum IgG Antibody Levels Expressed as SCRs - Phase 2 [ Time Frame: Day 35 ]; 4) Participants with Solicited Adverse Events (AEs) - Phase 2 [ Time Frame: 28 days ]; 5) Participants with Unsolicited AEs - Phase 2 [ Time Frame: 35 days ]
In the report
1)Proportion of patients with solicited adverse events for 7 days following each primary vaccination and unsolicited adverse events up until day 35.
2)Serum IgG antibody concentrations specific for the SARS-CoV-2 rS protein antigen detected by ELISA using GMT or seroconversion rate (ie, the proportion of participants with >4-fold increases in antibody titres compared with baseline) for the two-dose regimens by dose at day 35 and have previously been reported
Documents
available

Protocol

Yes. In English

Statistical plan

Yes

Data-sharing stated: Yes
Data accessibility: Data will be shared at the required timelines to https://clinicaltrials.gov/ct2/show/NCT04368988. Additional requests will be considered on publication of the manuscript by request to the corresponding author. Corresponding author: Raburn Mallory, RMallory@novavax.com
Risk of bias
Overall
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
*
General comment In addition to the pre-print, the trial registry was used in data extraction and risk of bias assessment. Neither protocol nor statistical plan was available. This study is an extension of Formica 2021. The study re-randomized participants who had received primary 2-dose schedule, to receive booster or placebo. In addition, the placebo group from the original trial was also followed up without receiving any further intervention. No extractable comparative data were reported for booster versus placebo: immunogenicity outcomes reported only for the booster arm; safety data not reported in a suitable format for extraction. This trial was updated on October 21st, 2022 after publication of the study report.