Trial Outcomes & Findings for Trial of the Immunogenicity, Safety, and Tolerability of rF1V Vaccine With CpG 1018® Adjuvant Compared With rF1V Vaccine in Adults 18 to 55 Years of Age (NCT NCT05506969)
NCT ID: NCT05506969
Last Updated: 2025-07-29
Results Overview
Rates of solicited local and systemic post-injection reactions, and AEs, severe AEs, SAEs, AESIs, and deaths
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
200 participants
Primary outcome timeframe
Day 1 to Week 56
Results posted on
2025-07-29
Participant Flow
Participant milestones
| Measure |
rF1V-1018 Co-Administered
rF1V vaccine and CpG 1018® adjuvant administered on Days 1 and 29, and 2 injections of placebo administered on Day 183
|
rF1V-1018 Bedside Mix
Bedside mix of rF1V vaccine and CpG 1018® adjuvant administered on Days 1 and 29, and 2 injections of placebo administered on Day 183
|
rF1V Vaccine Only
rF1V vaccine administered on Days 1, 29, and 183
|
|---|---|---|---|
|
Overall Study
STARTED
|
21
|
90
|
89
|
|
Overall Study
COMPLETED
|
18
|
81
|
77
|
|
Overall Study
NOT COMPLETED
|
3
|
9
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial of the Immunogenicity, Safety, and Tolerability of rF1V Vaccine With CpG 1018® Adjuvant Compared With rF1V Vaccine in Adults 18 to 55 Years of Age
Baseline characteristics by cohort
| Measure |
rF1V-1018 Co-Administered
n=21 Participants
rF1V vaccine and CpG 1018® adjuvant administered on Days 1 and 29, and 2 injections of placebo administered on Day 183
|
rF1V-1018 Bedside Mix
n=90 Participants
Bedside mix of rF1V vaccine and CpG 1018® adjuvant administered on Days 1 and 29, and 2 injections of placebo administered on Day 183
|
rF1V Vaccine Only
n=89 Participants
rF1V vaccine administered on Days 1, 29, and 183
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
Mean (SD)
|
39.1 Years
STANDARD_DEVIATION 8.17 • n=5 Participants
|
40.0 Years
STANDARD_DEVIATION 9.2 • n=7 Participants
|
37.9 Years
STANDARD_DEVIATION 9.91 • n=5 Participants
|
39.0 Years
STANDARD_DEVIATION 9.76 • n=4 Participants
|
|
Age, Customized
18-39
|
12 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
100 Participants
n=4 Participants
|
|
Age, Customized
40+
|
9 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
100 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
121 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
175 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
14 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
138 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Body mass index
|
26.5 (kg/m^2)
STANDARD_DEVIATION 2.46 • n=5 Participants
|
25.9 (kg/m^2)
STANDARD_DEVIATION 3.04 • n=7 Participants
|
25.5 (kg/m^2)
STANDARD_DEVIATION 3.16 • n=5 Participants
|
25.8 (kg/m^2)
STANDARD_DEVIATION 3.04 • n=4 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Week 56Population: Safety analysis population: All participants who received at least 1 study injection and had any post-baseline safety data
Rates of solicited local and systemic post-injection reactions, and AEs, severe AEs, SAEs, AESIs, and deaths
Outcome measures
| Measure |
rF1V-1018 Co-Administered
n=21 Participants
rF1V vaccine and CpG 1018® adjuvant administered on Days 1 and 29, and 2 injections of placebo administered on Day 183
|
rF1V-1018 Bedside Mix
n=90 Participants
Bedside mix of rF1V vaccine and CpG 1018® adjuvant administered on Days 1 and 29, and 2 injections of placebo administered on Day 183
|
rF1V Vaccine Only
n=89 Participants
rF1V vaccine administered on Days 1, 29, and 183
|
|---|---|---|---|
|
Rates of Reactogenicity and Safety
Local Reactions
|
16 Participants
|
67 Participants
|
57 Participants
|
|
Rates of Reactogenicity and Safety
Severe Local Reactions
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Rates of Reactogenicity and Safety
Systemic Reactions
|
13 Participants
|
60 Participants
|
42 Participants
|
|
Rates of Reactogenicity and Safety
Severe Systemic Reactions
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Rates of Reactogenicity and Safety
At least 1 Unsolicited AE
|
7 Participants
|
27 Participants
|
28 Participants
|
|
Rates of Reactogenicity and Safety
Severe (Grade 3 or 4) AEs
|
2 Participants
|
1 Participants
|
5 Participants
|
|
Rates of Reactogenicity and Safety
SAEs
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Rates of Reactogenicity and Safety
AESIs
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Rates of Reactogenicity and Safety
Deaths
|
0 Participants
|
0 Participants
|
1 Participants
|
Adverse Events
rF1V-1018 Co-Administered
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
rF1V-1018 Bedside Mix
Serious events: 0 serious events
Other events: 77 other events
Deaths: 0 deaths
rF1V Vaccine Only
Serious events: 3 serious events
Other events: 69 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
rF1V-1018 Co-Administered
n=21 participants at risk
rF1V vaccine and CpG 1018® adjuvant administered on Days 1 and 29, and 2 injections of placebo administered on Day 183
|
rF1V-1018 Bedside Mix
n=90 participants at risk
Bedside mix of rF1V vaccine and CpG 1018® adjuvant administered on Days 1 and 29, and 2 injections of placebo administered on Day 183
|
rF1V Vaccine Only
n=89 participants at risk
rF1V vaccine administered on Days 1, 29, and 183
|
|---|---|---|---|
|
Cardiac disorders
Cor Pulmonale Acute
|
4.8%
1/21 • Participants were followed for post-injection local and systemic reaction for 7 days post each injection and for AEs, SAEs, and imAESIs through Day 393 (Week 56).
|
0.00%
0/90 • Participants were followed for post-injection local and systemic reaction for 7 days post each injection and for AEs, SAEs, and imAESIs through Day 393 (Week 56).
|
0.00%
0/89 • Participants were followed for post-injection local and systemic reaction for 7 days post each injection and for AEs, SAEs, and imAESIs through Day 393 (Week 56).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
4.8%
1/21 • Participants were followed for post-injection local and systemic reaction for 7 days post each injection and for AEs, SAEs, and imAESIs through Day 393 (Week 56).
|
0.00%
0/90 • Participants were followed for post-injection local and systemic reaction for 7 days post each injection and for AEs, SAEs, and imAESIs through Day 393 (Week 56).
|
0.00%
0/89 • Participants were followed for post-injection local and systemic reaction for 7 days post each injection and for AEs, SAEs, and imAESIs through Day 393 (Week 56).
|
|
Vascular disorders
Deep Vein Thrombosis
|
4.8%
1/21 • Participants were followed for post-injection local and systemic reaction for 7 days post each injection and for AEs, SAEs, and imAESIs through Day 393 (Week 56).
|
0.00%
0/90 • Participants were followed for post-injection local and systemic reaction for 7 days post each injection and for AEs, SAEs, and imAESIs through Day 393 (Week 56).
|
0.00%
0/89 • Participants were followed for post-injection local and systemic reaction for 7 days post each injection and for AEs, SAEs, and imAESIs through Day 393 (Week 56).
|
|
Infections and infestations
Complicated Appendicitis
|
0.00%
0/21 • Participants were followed for post-injection local and systemic reaction for 7 days post each injection and for AEs, SAEs, and imAESIs through Day 393 (Week 56).
|
0.00%
0/90 • Participants were followed for post-injection local and systemic reaction for 7 days post each injection and for AEs, SAEs, and imAESIs through Day 393 (Week 56).
|
1.1%
1/89 • Participants were followed for post-injection local and systemic reaction for 7 days post each injection and for AEs, SAEs, and imAESIs through Day 393 (Week 56).
|
|
Infections and infestations
Appendicitis
|
0.00%
0/21 • Participants were followed for post-injection local and systemic reaction for 7 days post each injection and for AEs, SAEs, and imAESIs through Day 393 (Week 56).
|
0.00%
0/90 • Participants were followed for post-injection local and systemic reaction for 7 days post each injection and for AEs, SAEs, and imAESIs through Day 393 (Week 56).
|
1.1%
1/89 • Participants were followed for post-injection local and systemic reaction for 7 days post each injection and for AEs, SAEs, and imAESIs through Day 393 (Week 56).
|
|
Injury, poisoning and procedural complications
Toxicity to Various Agents
|
0.00%
0/21 • Participants were followed for post-injection local and systemic reaction for 7 days post each injection and for AEs, SAEs, and imAESIs through Day 393 (Week 56).
|
0.00%
0/90 • Participants were followed for post-injection local and systemic reaction for 7 days post each injection and for AEs, SAEs, and imAESIs through Day 393 (Week 56).
|
1.1%
1/89 • Participants were followed for post-injection local and systemic reaction for 7 days post each injection and for AEs, SAEs, and imAESIs through Day 393 (Week 56).
|
Other adverse events
| Measure |
rF1V-1018 Co-Administered
n=21 participants at risk
rF1V vaccine and CpG 1018® adjuvant administered on Days 1 and 29, and 2 injections of placebo administered on Day 183
|
rF1V-1018 Bedside Mix
n=90 participants at risk
Bedside mix of rF1V vaccine and CpG 1018® adjuvant administered on Days 1 and 29, and 2 injections of placebo administered on Day 183
|
rF1V Vaccine Only
n=89 participants at risk
rF1V vaccine administered on Days 1, 29, and 183
|
|---|---|---|---|
|
General disorders
Chills
|
14.3%
3/21 • Participants were followed for post-injection local and systemic reaction for 7 days post each injection and for AEs, SAEs, and imAESIs through Day 393 (Week 56).
|
14.4%
13/90 • Participants were followed for post-injection local and systemic reaction for 7 days post each injection and for AEs, SAEs, and imAESIs through Day 393 (Week 56).
|
15.7%
14/89 • Participants were followed for post-injection local and systemic reaction for 7 days post each injection and for AEs, SAEs, and imAESIs through Day 393 (Week 56).
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
7/21 • Participants were followed for post-injection local and systemic reaction for 7 days post each injection and for AEs, SAEs, and imAESIs through Day 393 (Week 56).
|
16.7%
15/90 • Participants were followed for post-injection local and systemic reaction for 7 days post each injection and for AEs, SAEs, and imAESIs through Day 393 (Week 56).
|
13.5%
12/89 • Participants were followed for post-injection local and systemic reaction for 7 days post each injection and for AEs, SAEs, and imAESIs through Day 393 (Week 56).
|
|
General disorders
Fatigue
|
47.6%
10/21 • Participants were followed for post-injection local and systemic reaction for 7 days post each injection and for AEs, SAEs, and imAESIs through Day 393 (Week 56).
|
47.8%
43/90 • Participants were followed for post-injection local and systemic reaction for 7 days post each injection and for AEs, SAEs, and imAESIs through Day 393 (Week 56).
|
33.7%
30/89 • Participants were followed for post-injection local and systemic reaction for 7 days post each injection and for AEs, SAEs, and imAESIs through Day 393 (Week 56).
|
|
Nervous system disorders
Headache
|
38.1%
8/21 • Participants were followed for post-injection local and systemic reaction for 7 days post each injection and for AEs, SAEs, and imAESIs through Day 393 (Week 56).
|
37.8%
34/90 • Participants were followed for post-injection local and systemic reaction for 7 days post each injection and for AEs, SAEs, and imAESIs through Day 393 (Week 56).
|
28.1%
25/89 • Participants were followed for post-injection local and systemic reaction for 7 days post each injection and for AEs, SAEs, and imAESIs through Day 393 (Week 56).
|
|
General disorders
Injection Site Pain
|
76.2%
16/21 • Participants were followed for post-injection local and systemic reaction for 7 days post each injection and for AEs, SAEs, and imAESIs through Day 393 (Week 56).
|
73.3%
66/90 • Participants were followed for post-injection local and systemic reaction for 7 days post each injection and for AEs, SAEs, and imAESIs through Day 393 (Week 56).
|
62.9%
56/89 • Participants were followed for post-injection local and systemic reaction for 7 days post each injection and for AEs, SAEs, and imAESIs through Day 393 (Week 56).
|
|
General disorders
Injection Site Pruritus
|
9.5%
2/21 • Participants were followed for post-injection local and systemic reaction for 7 days post each injection and for AEs, SAEs, and imAESIs through Day 393 (Week 56).
|
18.9%
17/90 • Participants were followed for post-injection local and systemic reaction for 7 days post each injection and for AEs, SAEs, and imAESIs through Day 393 (Week 56).
|
14.6%
13/89 • Participants were followed for post-injection local and systemic reaction for 7 days post each injection and for AEs, SAEs, and imAESIs through Day 393 (Week 56).
|
|
General disorders
Malaise
|
28.6%
6/21 • Participants were followed for post-injection local and systemic reaction for 7 days post each injection and for AEs, SAEs, and imAESIs through Day 393 (Week 56).
|
27.8%
25/90 • Participants were followed for post-injection local and systemic reaction for 7 days post each injection and for AEs, SAEs, and imAESIs through Day 393 (Week 56).
|
23.6%
21/89 • Participants were followed for post-injection local and systemic reaction for 7 days post each injection and for AEs, SAEs, and imAESIs through Day 393 (Week 56).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
42.9%
9/21 • Participants were followed for post-injection local and systemic reaction for 7 days post each injection and for AEs, SAEs, and imAESIs through Day 393 (Week 56).
|
25.6%
23/90 • Participants were followed for post-injection local and systemic reaction for 7 days post each injection and for AEs, SAEs, and imAESIs through Day 393 (Week 56).
|
24.7%
22/89 • Participants were followed for post-injection local and systemic reaction for 7 days post each injection and for AEs, SAEs, and imAESIs through Day 393 (Week 56).
|
|
Gastrointestinal disorders
Nausea
|
19.0%
4/21 • Participants were followed for post-injection local and systemic reaction for 7 days post each injection and for AEs, SAEs, and imAESIs through Day 393 (Week 56).
|
14.4%
13/90 • Participants were followed for post-injection local and systemic reaction for 7 days post each injection and for AEs, SAEs, and imAESIs through Day 393 (Week 56).
|
13.5%
12/89 • Participants were followed for post-injection local and systemic reaction for 7 days post each injection and for AEs, SAEs, and imAESIs through Day 393 (Week 56).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
9.5%
2/21 • Participants were followed for post-injection local and systemic reaction for 7 days post each injection and for AEs, SAEs, and imAESIs through Day 393 (Week 56).
|
0.00%
0/90 • Participants were followed for post-injection local and systemic reaction for 7 days post each injection and for AEs, SAEs, and imAESIs through Day 393 (Week 56).
|
0.00%
0/89 • Participants were followed for post-injection local and systemic reaction for 7 days post each injection and for AEs, SAEs, and imAESIs through Day 393 (Week 56).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/21 • Participants were followed for post-injection local and systemic reaction for 7 days post each injection and for AEs, SAEs, and imAESIs through Day 393 (Week 56).
|
5.6%
5/90 • Participants were followed for post-injection local and systemic reaction for 7 days post each injection and for AEs, SAEs, and imAESIs through Day 393 (Week 56).
|
3.4%
3/89 • Participants were followed for post-injection local and systemic reaction for 7 days post each injection and for AEs, SAEs, and imAESIs through Day 393 (Week 56).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place