Trial NCT04405908
Publication Richmond P, Lancet, 2021
Dates: 19/06/2020 to 23/09/2020
Funding: Mixed (Coalition for Epidemic Preparedness Innovations (CEPI))
Conflict of interest: Yes

Methods
RCT
Location : Single center / Australia
Follow-up duration (months): 1.64
18 – 54y • 3 mcg SCB-2019 (n = 8) • 3 mcg SCB-2019 + AS03 (n = 16) • 3 mcg SCB-2019 + CpG/Alum (n = 16) • 9 mcg SCB-2019 (n = 8) • 9 mcg SCB-2019 + AS03 (n = 16) • 9 mcg SCB-2019 + CpG/Alum (n = 16) • 30 mcg SCB-2019 (n = 9) • 30 mcg SCB-2019 + AS03 (n = 16) • 30 mcg SCB-2019 + CpG/Alum (n = 16) • Placebo (n = 30) 55 – 75y • 3 mcg SCB-2019 + AS03 (n = 8) • 3 mcg SCB-2019 + CpG/Alum (n = 8) • 9 mcg SCB-2019 + AS03 (n = 8) • 9 mcg SCB-2019 + CpG/Alum (n = 8) • 30 mcg SCB-2019 + AS03 (n = 8) • 30 mcg SCB-2019 + CpG/Alum (n = 8) • Placebo (n = 12)
Inclusion criteria
  • Adults of either sex from 18 to 75 years of age
  • healthy at enrolment based on medical history and medical assessment
  • negative serology for SARS COV-2 (prior infection)
  • negative reverse transcriptase-polymer chain reaction (acute exposure)
  • BMI between 18·5 and 35·0 kg/m2
  • available for the duration of the study (6 months)
  • female participants of childbearing potential were not to be pregnant or breastfeeding and had to agree to use protocol-approved forms of contraception until 6 months after the first vaccination
  • men were also to use a protocol-approved form of contraception from the day of first vaccination until 6 months after the first vaccination and refrain from donating sperm over the same period
  • informed consent.
Exclusion criteria
  • Positive serology for SARS-CoV-2
  • any uncontrolled chronic medical disorders
  • any known or suspected impairment of the immune system due to known immunosuppressive conditions or any therapy with immunosuppressants or immunostimulants
  • known allergy to any vaccine components
  • malignancies
  • a positive screening serology for HIV, hepatitis B or C
  • prior receipt of any other SARS-CoV-2 vaccine.
Interventions
Intervention
2 IM doses of 3-mcg SCB-2019, 21 days apart
2 IM doses of 3-mcg SCB-2019 + AS03 adjuvant, 21 days apart
2 IM doses of 3-mcg SCB-2019 + CpG + Alum adjuvant, 21 days apart
2 IM doses of 9-mcg SCB-2019, 21 days apart
2 IM doses of 9-mcg SCB-2019 + AS03 adjuvant, 21 days apart
2 IM doses of 9-mcg SCB-2019 + CpG + Alum adjuvant, 21 days apart
2 IM doses of 30-mcg SCB-2019, 21 days apart
2 IM doses of 30-mcg SCB-2019 + AS03 adjuvant, 21 days apart
2 IM doses of 30-mcg SCB-2019 + CpG + Alum adjuvant, 21 days apart
Control
2 IM doses of 0.5 mL normal saline, 21 days apart
Participants
Randomized
151 participants
Characteristics of participants
Type of participants: Healthy volunteers
N=151
64 males
Children: 0
Pregnant women: 0
Immunocompromized patients: 0
Mean age: 35.6
Age range: 20-50
Description of participants
Healthy SARS-CoV-2 serology/DNA negative adults aged 18-75 years at one study center in Australia
Primary outcome
In the register
Incidence of solicited adverse events (AEs) after vaccination [ Time Frame: 7 days after the first or second vaccination. ] ; Incidence of unsolicited AEs after vaccination [ Time Frame: Day 1 to Day 50 ] ; Immunogenicity(Anti-SCB-2019 Antibody Titers) [ Time Frame: Day 1 to Day 184 ] Geometric mean titer (GMT). Geometric mean ratio (GMR). Seroconversion rate (SCR) ; Incidence of serious AEs (SAEs) and adverse events of special interest (AESIs) [ Time Frame: Day 1 to Day 184 ]
In the report
The primary objective of this study was to assess the safety and reactogenicity of SCB-2019 when administered alone or as one of two adjuvanted formulations with AS03 or CpG and Alum. The primary immunogenicity endpoint was based on the anti-SCB-2019 IgG antibody titre at each blood sampling timepoint, measured by ELISA.
Documents
available

Protocol

Yes. In English

Statistical plan

Yes

Data-sharing stated: Yes, After publication and finalisation of the completed clinical study report for at least 1 year.
Data accessibility: The corresponding authors
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
Low
General comment In addition to the published article, the online trial registry and the study protocol were used for extraction and assessment of bias. This was an interim analysis of the first stage of a phase 1 trial, recruitment is completed and planned sample size has been reached, however, the study is still ongoing and long term follow-up will be reported separately. Participants in two age groups were randomised separately to various vaccine doses and adjuvant combinations, and to placebo. Results for some outcomes were reported combining the age groups whereas they were reported split by age groups for other outcomes. There were no major differences in population, procedures or interventions between the published article and registry.
This trial was updated on February 18th, 2021 after publication of study report.