Trial Outcomes & Findings for VELOCITY: An Anthrax Vaccine Clinical Study (NCT NCT03877926)

Last Updated: 2024-03-18

Results Overview

GMT of TNA NF50 at Day 64 in AV7909 study groups (Lots 1, 2 and 3) and BioThrax group. The outcome measure in AV7909 study groups was assessed for AV7909 lot-to-lot consistency, which was based on GMT TNA NF50 response at Day 64, wherein the 95% confidence interval (CI) for ratios of geometric mean titer (GMT) of TNA NF50 at Day 64 (seven weeks after second AV7909 vaccination) for each of the three AV7909 lot-to-lot comparisons had to be within equivalence margin of 0.5 and 2.0.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

3862 participants

Primary outcome timeframe

Day 64 (seven weeks after second AV7909 vaccination)

Results posted on

2024-03-18

Participant Flow

Participant milestones

Participant milestones
Measure	AV7909 Lot 1 Eligible participants randomized to receive AV7909 Lot 1. AV7909: AV7909 consists of Anthrax Vaccine Adsorbed (AVA) drug substance and CPG 7909 adjuvant. AVA drug substance in AV7909 is similar in composition and manufactured using the same process as commercial BioThrax® vaccine. CPG 7909 is an immunostimulatory synthetic oligodeoxynucleotide that functions as an adjuvant.	AV7909 Lot 2 Eligible participants randomized to receive AV7909 Lot 2. AV7909: AV7909 consists of Anthrax Vaccine Adsorbed (AVA) drug substance and CPG 7909 adjuvant. AVA drug substance in AV7909 is similar in composition and manufactured using the same process as commercial BioThrax vaccine. CPG 7909 is an immunostimulatory synthetic oligodeoxynucleotide that functions as an adjuvant.	AV7909 Lot 3 Eligible participants randomized to receive AV7909 Lot 3. AV7909: AV7909 consists of Anthrax Vaccine Adsorbed (AVA) drug substance and CPG 7909 adjuvant. AVA drug substance in AV7909 is similar in composition and manufactured using the same process as commercial BioThrax vaccine. CPG 7909 is an immunostimulatory synthetic oligodeoxynucleotide that functions as an adjuvant.	BioThrax Eligible participants randomized to receive BioThrax vaccine. BioThrax vaccine (Anthrax Vaccine Adsorbed; AVA) is licensed for post-exposure prophylaxis of anthrax disease.
Overall Study STARTED	1103	1103	1098	558
Overall Study Received at Least One Study Vaccination	1100	1102	1097	558
Overall Study Did Not Receive Any Study Vaccination	3	1	1	0
Overall Study COMPLETED	1032	1026	1035	537
Overall Study NOT COMPLETED	71	77	63	21

Reasons for withdrawal

Reasons for withdrawal
Measure	AV7909 Lot 1 Eligible participants randomized to receive AV7909 Lot 1. AV7909: AV7909 consists of Anthrax Vaccine Adsorbed (AVA) drug substance and CPG 7909 adjuvant. AVA drug substance in AV7909 is similar in composition and manufactured using the same process as commercial BioThrax® vaccine. CPG 7909 is an immunostimulatory synthetic oligodeoxynucleotide that functions as an adjuvant.	AV7909 Lot 2 Eligible participants randomized to receive AV7909 Lot 2. AV7909: AV7909 consists of Anthrax Vaccine Adsorbed (AVA) drug substance and CPG 7909 adjuvant. AVA drug substance in AV7909 is similar in composition and manufactured using the same process as commercial BioThrax vaccine. CPG 7909 is an immunostimulatory synthetic oligodeoxynucleotide that functions as an adjuvant.	AV7909 Lot 3 Eligible participants randomized to receive AV7909 Lot 3. AV7909: AV7909 consists of Anthrax Vaccine Adsorbed (AVA) drug substance and CPG 7909 adjuvant. AVA drug substance in AV7909 is similar in composition and manufactured using the same process as commercial BioThrax vaccine. CPG 7909 is an immunostimulatory synthetic oligodeoxynucleotide that functions as an adjuvant.	BioThrax Eligible participants randomized to receive BioThrax vaccine. BioThrax vaccine (Anthrax Vaccine Adsorbed; AVA) is licensed for post-exposure prophylaxis of anthrax disease.
Overall Study Adverse Event	1	0	0	0
Overall Study Death	2	2	2	0
Overall Study Lost to Follow-up	41	52	45	17
Overall Study Physician Decision	2	0	2	0
Overall Study Withdrawal by Subject	18	21	12	4
Overall Study Other - Various	4	1	1	0
Overall Study Not Treated	3	1	1	0

Baseline Characteristics

VELOCITY: An Anthrax Vaccine Clinical Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AV7909 Lot 1 n=1103 Participants Eligible participants randomized to receive AV7909 Lot 1.	AV7909 Lot 2 n=1103 Participants Eligible participants randomized to receive AV7909 Lot 2.	AV7909 Lot 3 n=1098 Participants Eligible participants randomized to receive AV7909 Lot 3.	BioThrax n=558 Participants Eligible participants randomized to receive BioThrax vaccine.	Total n=3862 Participants Total of all reporting groups
Age, Continuous	39.0 years STANDARD_DEVIATION 13.0 • n=5 Participants	39.2 years STANDARD_DEVIATION 13.1 • n=7 Participants	38.9 years STANDARD_DEVIATION 12.8 • n=5 Participants	38.6 years STANDARD_DEVIATION 12.4 • n=4 Participants	39.0 years STANDARD_DEVIATION 12.9 • n=21 Participants
Age, Customized 18-30 years	341 Participants n=5 Participants	355 Participants n=7 Participants	352 Participants n=5 Participants	176 Participants n=4 Participants	1224 Participants n=21 Participants
Age, Customized 31-50 years	502 Participants n=5 Participants	470 Participants n=7 Participants	488 Participants n=5 Participants	269 Participants n=4 Participants	1729 Participants n=21 Participants
Age, Customized 51-65 years	260 Participants n=5 Participants	278 Participants n=7 Participants	258 Participants n=5 Participants	113 Participants n=4 Participants	909 Participants n=21 Participants
Sex: Female, Male Female	650 Participants n=5 Participants	615 Participants n=7 Participants	647 Participants n=5 Participants	308 Participants n=4 Participants	2220 Participants n=21 Participants
Sex: Female, Male Male	453 Participants n=5 Participants	488 Participants n=7 Participants	451 Participants n=5 Participants	250 Participants n=4 Participants	1642 Participants n=21 Participants
Race/Ethnicity, Customized Race : American Indian or Alaska Native	4 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	2 Participants n=4 Participants	15 Participants n=21 Participants
Race/Ethnicity, Customized Race : Asian	17 Participants n=5 Participants	18 Participants n=7 Participants	24 Participants n=5 Participants	15 Participants n=4 Participants	74 Participants n=21 Participants
Race/Ethnicity, Customized Race : Black or African American	170 Participants n=5 Participants	186 Participants n=7 Participants	191 Participants n=5 Participants	89 Participants n=4 Participants	636 Participants n=21 Participants
Race/Ethnicity, Customized Race : Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	11 Participants n=21 Participants
Race/Ethnicity, Customized Race : White	878 Participants n=5 Participants	865 Participants n=7 Participants	852 Participants n=5 Participants	439 Participants n=4 Participants	3034 Participants n=21 Participants
Race/Ethnicity, Customized Race : More than One Race	22 Participants n=5 Participants	20 Participants n=7 Participants	14 Participants n=5 Participants	9 Participants n=4 Participants	65 Participants n=21 Participants
Race/Ethnicity, Customized Race : Other	8 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	1 Participants n=4 Participants	17 Participants n=21 Participants
Race/Ethnicity, Customized Race : Unknown	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	10 Participants n=21 Participants
Race/Ethnicity, Customized Ethnicity: Not Hispanic or Latino	910 Participants n=5 Participants	938 Participants n=7 Participants	945 Participants n=5 Participants	450 Participants n=4 Participants	3243 Participants n=21 Participants
Race/Ethnicity, Customized Ethnicity: Hispanic or Latino	177 Participants n=5 Participants	156 Participants n=7 Participants	142 Participants n=5 Participants	98 Participants n=4 Participants	573 Participants n=21 Participants
Race/Ethnicity, Customized Ethnicity: Unknown	4 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants	4 Participants n=4 Participants	18 Participants n=21 Participants
Race/Ethnicity, Customized Ethnicity: Not Reported	12 Participants n=5 Participants	7 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants	28 Participants n=21 Participants
Region of Enrollment United States	1103 Participants n=5 Participants	1103 Participants n=7 Participants	1098 Participants n=5 Participants	558 Participants n=4 Participants	3862 Participants n=21 Participants
Body Mass Index	26.9 kg/m^2 STANDARD_DEVIATION 4.3 • n=5 Participants	27.3 kg/m^2 STANDARD_DEVIATION 4.3 • n=7 Participants	27.2 kg/m^2 STANDARD_DEVIATION 4.3 • n=5 Participants	27.3 kg/m^2 STANDARD_DEVIATION 4.2 • n=4 Participants	27.1 kg/m^2 STANDARD_DEVIATION 4.3 • n=21 Participants

PRIMARY outcome

Timeframe: Day 64 (seven weeks after second AV7909 vaccination)

Population: Participants that met protocol-defined immunogenicity criteria from AV7909 Lot 1 group (n=878), AV7909 Lot 2 group (n=896), AV7909 Lot 3 group (n=896) and BioThrax group (n=454) are included.

Outcome measures

Outcome measures
Measure	BioThrax n=454 Participants Eligible participants randomized to receive BioThrax vaccine.	AV7909 Lot 1 n=878 Participants Eligible participants who received at least one dose of AV7909 Lot 1.	AV7909 Lot 2 n=896 Participants Eligible participants who received at least one dose of AV7909 Lot 2.	AV7909 Lot 3 n=896 Participants Eligible participants who received at least one dose of AV7909 Lot 3.
Geometric Mean Titer (GMT) of Toxin Neutralizing Antibody (TNA) 50% Neutralization Factor (NF50) at Day 64	0.335 Titer (TNA NF50) Interval 0.305 to 0.368	0.753 Titer (TNA NF50) Interval 0.708 to 0.8	0.746 Titer (TNA NF50) Interval 0.703 to 0.791	0.718 Titer (TNA NF50) Interval 0.676 to 0.763

PRIMARY outcome

Timeframe: Day 64 (seven weeks after second AV7909 vaccination)

Population: Data from participants that met protocol-defined criteria for inclusion in the immunogenicity population are included in the analysis; i.e., AV7909 Lot 1 n=878; AV7909 Lot 2 n=896; AV7909 Lot 3 n=896. Pre-defined success criteria (lower bound of the two-sided 95% CI to be ≥40% for the percentage of participants achieving a TNA NF50 ≥0.56 at Day 64) was only applicable for AV7909 study groups and not for BioThrax group; therefore, BioThrax group is not included.

Proportion of participants with TNA NF50 ≥0.56 at Day 64 in each AV7909 study groups (Lot 1, Lot 2, Lot 3). The assessment of the immune response in each study group was pre-defined as the lower bound of the two-sided 95% CI to be ≥40% for the percentage of AV7909 participants in each of the three lots achieving a TNA NF50 ≥0.56 at seven weeks after second AV7909 vaccination (Day 64).

Outcome measures

Outcome measures
Measure	BioThrax Eligible participants randomized to receive BioThrax vaccine.	AV7909 Lot 1 n=878 Participants Eligible participants who received at least one dose of AV7909 Lot 1.	AV7909 Lot 2 n=896 Participants Eligible participants who received at least one dose of AV7909 Lot 2.	AV7909 Lot 3 n=896 Participants Eligible participants who received at least one dose of AV7909 Lot 3.
Percentage of Participants in AV7909 Lot 1, Lot 2 and Lot 3 Groups Achieving a TNA NF50 ≥0.56 on Day 64	—	68.5 percentage of participants Interval 65.3 to 71.5	66.1 percentage of participants Interval 62.9 to 69.2	64.5 percentage of participants Interval 61.3 to 67.6

PRIMARY outcome

Timeframe: Day 64 (seven weeks after second AV7909 vaccination)

Population: Data from participants who met protocol-defined criteria for inclusion in the immunogenicity population from all three AV7909 study groups (i.e., pooled AV7909; n=2670) were used for the analysis. The pre-defined success criteria (lower bound of the two-sided 95% CI to be ≥40% for the percentage of participants achieving a TNA NF50 ≥0.56 on Day 64) was not applicable for BioThrax participants, therefore BioThrax group was not included.

Percentage of AV7909 participants (from all three AV7909 study groups pooled) achieving a TNA NF50 ≥0.56 on Day 64 (seven weeks after second AV7909 vaccination). The assessment of the immune response in AV7909 participants was pre-defined as the lower bound of the two-sided 95% CI for proportion of AV7909 participants with TNA NF50 ≥0.56 at Day 64 ≥40%.

Outcome measures

Outcome measures
Measure	BioThrax Eligible participants randomized to receive BioThrax vaccine.	AV7909 Lot 1 n=2670 Participants Eligible participants who received at least one dose of AV7909 Lot 1.	AV7909 Lot 2 Eligible participants who received at least one dose of AV7909 Lot 2.	AV7909 Lot 3 Eligible participants who received at least one dose of AV7909 Lot 3.
Percentage of AV7909 Participants Achieving a TNA NF50 ≥0.56 on Day 64	—	66.3 percentage of participants Interval 64.5 to 68.1	—	—

PRIMARY outcome

Timeframe: Day 64 (seven weeks after second AV7909 vaccination; five weeks after third BioThrax vaccination)

Population: Data from participants who met protocol-defined criteria for inclusion in the immunogenicity population from each AV7909 study group (Lot 1 n=878; Lot 2 n=896; Lot 3 n=896) and BioThrax group (n=454) were used in the analysis. For the non-inferiority assessment, participants who met pre-defined criteria (achievement of TNA NF50 ≥0.29 at Day 64) from the pooled AV7909 study groups 1-3 (AV7909 Lot 1, Lot 2, Lot 3; i.e., Pooled AV7909) and BioThrax group were included.

Proportion of AV7909 participants (in each AV7909 study groups) and BioThrax participants who achieved TNA NF50 ≥0.29 at Day 64. Non-inferiority of AV7909 vaccine to BioThrax vaccine at Day 64 was assessed as determined by the two-sided lower bound for the 95% CI of the difference in the percentage of AV7909 participants (three lots pooled) with a TNA NF50 ≥0.29 and the percentage of BioThrax participants with a TNA NF50 ≥0.29 being greater than -15%.

Outcome measures

Outcome measures
Measure	BioThrax n=454 Participants Eligible participants randomized to receive BioThrax vaccine.	AV7909 Lot 1 n=878 Participants Eligible participants who received at least one dose of AV7909 Lot 1.	AV7909 Lot 2 n=896 Participants Eligible participants who received at least one dose of AV7909 Lot 2.	AV7909 Lot 3 n=896 Participants Eligible participants who received at least one dose of AV7909 Lot 3.
Percentage of AV7909 Participants and BioThrax Participants With TNA NF50 ≥0.29 at Day 64	62.1 percentage of participants Interval 57.5 to 66.6	86.9 percentage of participants Interval 84.5 to 89.1	87.2 percentage of participants Interval 84.8 to 89.3	85.8 percentage of participants Interval 83.4 to 88.0

PRIMARY outcome

Timeframe: Day 1 though Day 394

Population: For the relative risk of SAE incidence analysis, participants from all three AV7909 study groups (Lot 1, Lot 2, Lot 3) since AV7909 lots 1, 2 and 3 were considered the same product (consecutively manufactured, and released with the same product specifications); hence, it was pre-defined to combine SAE data from participants across the three AV7909 lots for SAE relative risk analysis.

Number of AV7909 participants or BioThrax participants who received at least one vaccination and reported serious adverse event(s) (SAEs) from the time of the first vaccination on Day 1 through Day 394.

Outcome measures

Outcome measures
Measure	BioThrax n=558 Participants Eligible participants randomized to receive BioThrax vaccine.	AV7909 Lot 1 n=1100 Participants Eligible participants who received at least one dose of AV7909 Lot 1.	AV7909 Lot 2 n=1102 Participants Eligible participants who received at least one dose of AV7909 Lot 2.	AV7909 Lot 3 n=1097 Participants Eligible participants who received at least one dose of AV7909 Lot 3.
Incidence of Serious Adverse Events	4 Participants	21 Participants	16 Participants	21 Participants

SECONDARY outcome

Timeframe: Day 29 (two weeks after second AV7909 vaccination)

Population: Data from participants who met protocol-defined criteria for inclusion in the immunogenicity population (AV7909 study groups 1-3) were used in the analysis. The pre-defined success criteria (lower bound of the two-sided 95% CI to be ≥67% for the percentage of participants achieving a TNA NF50 ≥0.15 on Day 29) was not applicable for BioThrax, therefore BioThrax group was not included.

Proportion of AV7909 participants (in each AV7909 study group) who achieved TNA NF50 ≥0.15 at Day 29 (two weeks after second AV7909 vaccination). Assessment of the lower bound of the two-sided 95% CI to be ≥67% for the percentage of AV7909 participants in AV7909 study groups 1-3 (Pooled AV7909) achieving a TNA NF50 ≥0.15 on Day 29 was performed.

Outcome measures

Outcome measures
Measure	BioThrax Eligible participants randomized to receive BioThrax vaccine.	AV7909 Lot 1 n=863 Participants Eligible participants who received at least one dose of AV7909 Lot 1.	AV7909 Lot 2 n=878 Participants Eligible participants who received at least one dose of AV7909 Lot 2.	AV7909 Lot 3 n=876 Participants Eligible participants who received at least one dose of AV7909 Lot 3.
Percentage of AV7909 Participants Achieving a TNA NF50 ≥0.15 on Day 29.	—	98.1 percentage of participants Interval 97.0 to 98.9	97.9 percentage of participants Interval 96.8 to 98.8	97.4 percentage of participants Interval 96.1 to 98.3

SECONDARY outcome

Timeframe: Day 1 through Day 64

Population: Data from participants who received at least one dose of AV7909 vaccine Lot 1 (n=1100), Lot 2 (n=1102) or Lot 3 (n=1097) or BioThrax vaccine (n=558) are included in the analysis.

Number of AV7909 or BioThrax participants who received at least one vaccination and had at least one adverse event reported from the time of the first vaccination on Day 1 through Day 64.

Outcome measures

Outcome measures
Measure	BioThrax n=558 Participants Eligible participants randomized to receive BioThrax vaccine.	AV7909 Lot 1 n=1100 Participants Eligible participants who received at least one dose of AV7909 Lot 1.	AV7909 Lot 2 n=1102 Participants Eligible participants who received at least one dose of AV7909 Lot 2.	AV7909 Lot 3 n=1097 Participants Eligible participants who received at least one dose of AV7909 Lot 3.
Incidence of Adverse Events	210 Participants	410 Participants	400 Participants	408 Participants

SECONDARY outcome

Timeframe: Day 1 through Day 394

Population: Data from participants who received at least one dose of AV7909 vaccine (Lot 1, Lot 2 or Lot 3) or BioThrax vaccine are used in the analysis. Since AV7909 lots 1, 2 and 3 were considered the same product (consecutively manufactured, and released with the same product specifications), it was pre-defined to combine AESI data from participants across the three AV7909 lots for AESI relative risk analysis.

Incidence of adverse events of special interest (AESIs; events of autoimmune etiology) from the time of the first vaccination on Day 1 through Day 394 in participants who received at least one dose of AV7909 (Lot 1, Lot 2 or Lot 3) or BioThrax vaccines.

Outcome measures

Outcome measures
Measure	BioThrax n=558 Participants Eligible participants randomized to receive BioThrax vaccine.	AV7909 Lot 1 n=1100 Participants Eligible participants who received at least one dose of AV7909 Lot 1.	AV7909 Lot 2 n=1102 Participants Eligible participants who received at least one dose of AV7909 Lot 2.	AV7909 Lot 3 n=1097 Participants Eligible participants who received at least one dose of AV7909 Lot 3.
Incidence of Adverse Events of Special Interest (Events of Autoimmune Etiology)	2 Participants	5 Participants	4 Participants	6 Participants

SECONDARY outcome

Timeframe: Day 1-7, Day 15-21, Day 29-35 (within 7 days after each vaccination, inclusive of the vaccination day)

Population: Data from participants (solicited systemic reactogenicity events after any vaccination) who received at least one dose of AV7909 vaccine or BioThrax vaccine are included in the analysis.

Incidence of any solicited systemic reactogenicity reaction after any AV7909 or BioThrax vaccination.

Outcome measures

Outcome measures
Measure	BioThrax n=558 Participants Eligible participants randomized to receive BioThrax vaccine.	AV7909 Lot 1 n=1100 Participants Eligible participants who received at least one dose of AV7909 Lot 1.	AV7909 Lot 2 n=1102 Participants Eligible participants who received at least one dose of AV7909 Lot 2.	AV7909 Lot 3 n=1097 Participants Eligible participants who received at least one dose of AV7909 Lot 3.
Incidence of Solicited Systemic Reactogenicity Events	438 Participants	930 Participants	923 Participants	906 Participants

SECONDARY outcome

Timeframe: Day 1-7, Day 15-21, Day 29-35 (within 7 days after each vaccination, inclusive of the vaccination day)

Population: Data from participants who received at least one dose of AV7909 or BioThrax dose are included in the analysis.

Incidence of any solicited injection site reactogenicity reaction after any AV7909 (Lots 1, 2 or 3) or BioThrax vaccination.

Outcome measures

Outcome measures
Measure	BioThrax n=558 Participants Eligible participants randomized to receive BioThrax vaccine.	AV7909 Lot 1 n=1100 Participants Eligible participants who received at least one dose of AV7909 Lot 1.	AV7909 Lot 2 n=1102 Participants Eligible participants who received at least one dose of AV7909 Lot 2.	AV7909 Lot 3 n=1097 Participants Eligible participants who received at least one dose of AV7909 Lot 3.
Incidences of Solicited Injection Site Reactogenicity Events	525 Participants	1009 Participants	1010 Participants	1013 Participants

Adverse Events

AV7909 Lot 1

Serious events: 21 serious events

Other events: 193 other events

Deaths: 2 deaths

AV7909 Lot 2

Serious events: 16 serious events

Other events: 189 other events

Deaths: 2 deaths

AV7909 Lot 3

Serious events: 21 serious events

Other events: 120 other events

Deaths: 2 deaths

BioThrax

Serious events: 4 serious events

Other events: 110 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Bojan Drobic, Director, Clinical Research

Emergent BioSolutions Inc.

Phone: 204 275 4196

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place