Trial Outcomes & Findings for Phase I, Randomized, Double-blinded, Placebo-Controlled Dose De-escalation Study to Evaluate Safety and Immunogenicity of Alum Adjuvanted Zika Virus Purified Inactivated Vaccine (ZPIV) in Adults in a Flavivirus Endemic Area (NCT NCT03008122)

Results Overview

The following systemic solicited events were measured: feverishness, fatigue, malaise, myalgia, arthralgia, headache, nausea, vomiting, diarrhea, abdominal pain, rash, and fever. Participants who reported not having a symptom are listed as "None", while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as "Not Reported". Severity is the maximum severity reported over all solicited symptoms post dosing for each participant.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

91 participants

Primary outcome timeframe

Day 1 through Day 8

Results posted on

2023-04-06

Participant Flow

Participants were healthy males and non-pregnant females between 21 and 49 years old, inclusively. They were recruited from the community at large around the clinic site. The enrollment period occurred between 21MAR2017 and 18JUL2019.

Participant milestones

Participant milestones
Measure	2.5 mcg ZPIV 2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29. Zika Virus Purified Inactivated Vaccine (ZPIV): Zika Virus Purified Inactivated Vaccine with aluminum hydroxide adjuvant using a 2015 Puerto Rico isolate (PRVABC59 strain).	5 mcg ZPIV 5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29. Zika Virus Purified Inactivated Vaccine (ZPIV): Zika Virus Purified Inactivated Vaccine with aluminum hydroxide adjuvant using a 2015 Puerto Rico isolate (PRVABC59 strain).	Placebo Placebo administered intramuscularly on Day 1 and Day 29. Normal saline (0.9% sodium chloride injection, USP) is a clear to colorless, sterile, nonpyrogenic, isotonic solution.
Overall Study STARTED	36	45	10
Overall Study COMPLETED	26	32	6
Overall Study NOT COMPLETED	10	13	4

Reasons for withdrawal

Reasons for withdrawal
Measure	2.5 mcg ZPIV 2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29. Zika Virus Purified Inactivated Vaccine (ZPIV): Zika Virus Purified Inactivated Vaccine with aluminum hydroxide adjuvant using a 2015 Puerto Rico isolate (PRVABC59 strain).	5 mcg ZPIV 5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29. Zika Virus Purified Inactivated Vaccine (ZPIV): Zika Virus Purified Inactivated Vaccine with aluminum hydroxide adjuvant using a 2015 Puerto Rico isolate (PRVABC59 strain).	Placebo Placebo administered intramuscularly on Day 1 and Day 29. Normal saline (0.9% sodium chloride injection, USP) is a clear to colorless, sterile, nonpyrogenic, isotonic solution.
Overall Study Physician Decision	3	2	0
Overall Study Withdrawal by Subject	1	3	0
Overall Study Lost to Follow-up	4	8	3
Overall Study Failure to Meet Randomization Criteria	1	0	0
Overall Study Subject Unable to Attend Clinical Visit	1	0	0
Overall Study Death	0	0	1

Baseline Characteristics

Phase I, Randomized, Double-blinded, Placebo-Controlled Dose De-escalation Study to Evaluate Safety and Immunogenicity of Alum Adjuvanted Zika Virus Purified Inactivated Vaccine (ZPIV) in Adults in a Flavivirus Endemic Area

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	2.5 mcg ZPIV n=36 Participants 2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29. Zika Virus Purified Inactivated Vaccine (ZPIV): Zika Virus Purified Inactivated Vaccine with aluminum hydroxide adjuvant using a 2015 Puerto Rico isolate (PRVABC59 strain).	5 mcg ZPIV n=45 Participants 5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29. Zika Virus Purified Inactivated Vaccine (ZPIV): Zika Virus Purified Inactivated Vaccine with aluminum hydroxide adjuvant using a 2015 Puerto Rico isolate (PRVABC59 strain).	Placebo n=10 Participants Placebo administered intramuscularly on Day 1 and Day 29. Normal saline (0.9% sodium chloride injection, USP) is a clear to colorless, sterile, nonpyrogenic, isotonic solution.	Total n=91 Participants Total of all reporting groups
Age, Continuous	31.4 years STANDARD_DEVIATION 9.0 • n=5 Participants	30.5 years STANDARD_DEVIATION 8.0 • n=7 Participants	28.6 years STANDARD_DEVIATION 8.0 • n=5 Participants	30.7 years STANDARD_DEVIATION 8.4 • n=4 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	25 Participants n=7 Participants	6 Participants n=5 Participants	49 Participants n=4 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	20 Participants n=7 Participants	4 Participants n=5 Participants	42 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	36 Participants n=5 Participants	45 Participants n=7 Participants	10 Participants n=5 Participants	91 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	15 Participants n=7 Participants	2 Participants n=5 Participants	19 Participants n=4 Participants
Race (NIH/OMB) More than one race	34 Participants n=5 Participants	18 Participants n=7 Participants	5 Participants n=5 Participants	57 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	12 Participants n=7 Participants	3 Participants n=5 Participants	15 Participants n=4 Participants
Region of Enrollment Puerto Rico	36 participants n=5 Participants	45 participants n=7 Participants	10 participants n=5 Participants	91 participants n=4 Participants
Baseline ZIKV Immune Status Baseline ZIKV Seropositive	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Baseline ZIKV Immune Status Baseline ZIKV Seronegative	34 Participants n=5 Participants	43 Participants n=7 Participants	10 Participants n=5 Participants	87 Participants n=4 Participants
Baseline ZIKV Immune Status Unknown	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Baseline Flavivirus Immune Status Baseline ZIKV Seropositive and DENV Seropositive	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Baseline Flavivirus Immune Status Baseline ZIKV Seropositive and DENV Seronegative	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Baseline Flavivirus Immune Status Baseline ZIKV Seronegative and DENV Seropositive	26 Participants n=5 Participants	33 Participants n=7 Participants	9 Participants n=5 Participants	68 Participants n=4 Participants
Baseline Flavivirus Immune Status Baseline ZIKV Seronegative and DENV Seronegative	8 Participants n=5 Participants	10 Participants n=7 Participants	1 Participants n=5 Participants	19 Participants n=4 Participants
Baseline Flavivirus Immune Status Unknown	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
BMI	27.59 kg/m^2 STANDARD_DEVIATION 4.09 • n=5 Participants	26.51 kg/m^2 STANDARD_DEVIATION 3.73 • n=7 Participants	29.20 kg/m^2 STANDARD_DEVIATION 4.53 • n=5 Participants	27.23 kg/m^2 STANDARD_DEVIATION 4.01 • n=4 Participants

PRIMARY outcome

Timeframe: Day 1 through Day 8

Population: The Safety Analysis population includes all participants who received at least one study vaccination.

The following injection site reactogenicity events were measured: pain, tenderness, pruritus, ecchymosis, erythema, and induration. Participants who reported not having a symptom are listed as "None", while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as "Not Reported". Severity is the maximum severity reported over all solicited symptoms post dosing for each participant.

Outcome measures

Outcome measures
Measure	2.5 mcg ZPIV n=35 Participants 2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.	5 mcg ZPIV n=45 Participants 5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.	Placebo n=10 Participants Placebo administered intramuscularly on Day 1 and Day 29.
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants Any Local Symptom · Mild	18 Participants	22 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants Pain · None	22 Participants	28 Participants	10 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants Erythema · Severe	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants Erythema · Not Reported	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants Induration · Not Reported	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants Ecchymosis · Mild	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants Ecchymosis · Moderate	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants Tenderness · Moderate	1 Participants	1 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants Any Local Symptom · None	15 Participants	22 Participants	10 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants Any Local Symptom · Moderate	2 Participants	1 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants Any Local Symptom · Severe	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants Any Local Symptom · Not Reported	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants Pain · Mild	11 Participants	16 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants Pain · Moderate	2 Participants	1 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants Pain · Severe	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants Pain · Not Reported	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants Erythema · None	32 Participants	45 Participants	10 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants Erythema · Mild	3 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants Erythema · Moderate	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants Induration · None	33 Participants	44 Participants	10 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants Induration · Mild	2 Participants	1 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants Induration · Moderate	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants Induration · Severe	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants Pruritus · None	34 Participants	43 Participants	10 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants Pruritus · Mild	1 Participants	2 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants Pruritus · Moderate	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants Pruritus · Severe	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants Pruritus · Not Reported	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants Ecchymosis · None	35 Participants	45 Participants	10 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants Ecchymosis · Severe	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants Ecchymosis · Not Reported	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants Tenderness · None	21 Participants	29 Participants	10 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants Tenderness · Mild	13 Participants	15 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants Tenderness · Severe	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for All Participants Tenderness · Not Reported	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 29 through Day 36

Population: The Safety Analysis population includes all participants with available results who received at least one study vaccination.

The following injection site reactogenicity events were measured: pain, tenderness, pruritus, ecchymosis, erythema, and induration. Participants who reported not having a symptom are listed as "None", while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as "Not Reported". Severity is the maximum severity reported over all solicited symptoms post dosing for each participant.

Outcome measures

Outcome measures
Measure	2.5 mcg ZPIV n=32 Participants 2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.	5 mcg ZPIV n=43 Participants 5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.	Placebo n=9 Participants Placebo administered intramuscularly on Day 1 and Day 29.
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants Any Local Symptom · Severe	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants Erythema · None	31 Participants	43 Participants	9 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants Ecchymosis · Not Reported	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants Tenderness · Severe	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants Any Local Symptom · None	17 Participants	33 Participants	9 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants Any Local Symptom · Mild	15 Participants	7 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants Any Local Symptom · Moderate	0 Participants	3 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants Any Local Symptom · Not Reported	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants Pain · None	20 Participants	36 Participants	9 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants Pain · Mild	12 Participants	4 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants Pain · Moderate	0 Participants	3 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants Pain · Severe	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants Pain · Not Reported	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants Erythema · Mild	1 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants Erythema · Moderate	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants Erythema · Severe	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants Erythema · Not Reported	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants Induration · None	31 Participants	43 Participants	9 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants Induration · Mild	1 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants Induration · Moderate	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants Induration · Severe	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants Induration · Not Reported	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants Pruritus · None	30 Participants	42 Participants	9 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants Pruritus · Mild	2 Participants	1 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants Pruritus · Moderate	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants Pruritus · Severe	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants Pruritus · Not Reported	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants Ecchymosis · None	32 Participants	43 Participants	9 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants Ecchymosis · Mild	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants Ecchymosis · Moderate	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants Ecchymosis · Severe	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants Tenderness · None	25 Participants	34 Participants	9 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants Tenderness · Mild	7 Participants	6 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants Tenderness · Moderate	0 Participants	3 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for All Participants Tenderness · Not Reported	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 1 through Day 8

Population: The Safety Analysis population includes all baseline ZIKV seropositive participants who received at least one study vaccination.

The following injection site reactogenicity events were measured: pain, tenderness, pruritus, ecchymosis, erythema, and induration. Participants who reported not having a symptom are listed as "None", while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as "Not Reported". Severity is the maximum severity reported over all solicited symptoms post dosing for each participant.

Outcome measures

Outcome measures
Measure	2.5 mcg ZPIV n=1 Participants 2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.	5 mcg ZPIV n=1 Participants 5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.	Placebo Placebo administered intramuscularly on Day 1 and Day 29.
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants Erythema · Severe	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants Erythema · Not reported	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants Pain · None	0 Participants	1 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants Any Local Symptom · None	0 Participants	1 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants Any Local Symptom · Mild	1 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants Any Local Symptom · Moderate	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants Any Local Symptom · Severe	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants Any Local Symptom · Not reported	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants Pain · Severe	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants Erythema · None	1 Participants	1 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants Induration · None	1 Participants	1 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants Ecchymosis · Moderate	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants Tenderness · Mild	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants Tenderness · Moderate	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants Tenderness · Severe	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants Induration · Mild	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants Induration · Moderate	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants Induration · Severe	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants Induration · Not reported	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants Pruritus · None	1 Participants	1 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants Pruritus · Mild	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants Pruritus · Moderate	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants Pruritus · Severe	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants Pruritus · Not reported	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants Ecchymosis · None	1 Participants	1 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants Ecchymosis · Mild	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants Ecchymosis · Severe	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants Ecchymosis · Not reported	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants Tenderness · None	1 Participants	1 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants Tenderness · Not reported	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants Erythema · Moderate	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants Pain · Mild	1 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants Pain · Moderate	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants Pain · Not reported	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive Participants Erythema · Mild	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 29 through Day 36

Population: The Safety Analysis population includes all baseline ZIKV seropositive participants who received at least one study vaccination.

The following injection site reactogenicity events were measured: pain, tenderness, pruritus, ecchymosis, erythema, and induration. Participants who reported not having a symptom are listed as "None", while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as "Not Reported". Severity is the maximum severity reported over all solicited symptoms post dosing for each participant.

Outcome measures

Outcome measures
Measure	2.5 mcg ZPIV n=1 Participants 2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.	5 mcg ZPIV n=1 Participants 5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.	Placebo Placebo administered intramuscularly on Day 1 and Day 29.
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants Any Local Symptom · Not reported	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants Erythema · Moderate	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants Induration · None	1 Participants	1 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants Induration · Not reported	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants Pruritus · None	1 Participants	1 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants Pruritus · Mild	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants Pruritus · Moderate	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants Pruritus · Severe	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants Any Local Symptom · None	0 Participants	1 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants Any Local Symptom · Mild	1 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants Any Local Symptom · Moderate	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants Any Local Symptom · Severe	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants Pain · None	0 Participants	1 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants Pain · Mild	1 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants Pain · Moderate	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants Pain · Severe	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants Pain · Not reported	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants Erythema · None	1 Participants	1 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants Erythema · Mild	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants Erythema · Severe	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants Erythema · Not reported	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants Induration · Mild	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants Induration · Moderate	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants Induration · Severe	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants Pruritus · Not reported	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants Ecchymosis · None	1 Participants	1 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants Ecchymosis · Mild	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants Ecchymosis · Moderate	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants Ecchymosis · Severe	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants Ecchymosis · Not reported	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants Tenderness · None	0 Participants	1 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants Tenderness · Mild	1 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants Tenderness · Moderate	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants Tenderness · Severe	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive Participants Tenderness · Not reported	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 1 through Day 8

Population: The Safety Analysis population includes all baseline ZIKV seronegative participants who received at least one study vaccination.

The following injection site reactogenicity events were measured: pain, tenderness, pruritus, ecchymosis, erythema, and induration. Participants who reported not having a symptom are listed as "None", while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as "Not Reported". Severity is the maximum severity reported over all solicited symptoms post dosing for each participant.

Outcome measures

Outcome measures
Measure	2.5 mcg ZPIV n=34 Participants 2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.	5 mcg ZPIV n=43 Participants 5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.	Placebo n=10 Participants Placebo administered intramuscularly on Day 1 and Day 29.
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants Induration · Not Reported	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants Pruritus · None	33 Participants	41 Participants	10 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants Pruritus · Severe	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants Any Local Symptom · Moderate	2 Participants	1 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants Any Local Symptom · Severe	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants Any Local Symptom · Not Reported	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants Induration · None	32 Participants	42 Participants	10 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants Induration · Mild	2 Participants	1 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants Induration · Severe	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants Ecchymosis · None	34 Participants	43 Participants	10 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants Any Local Symptom · None	15 Participants	21 Participants	10 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants Any Local Symptom · Mild	17 Participants	21 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants Pain · None	22 Participants	27 Participants	10 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants Pain · Mild	10 Participants	15 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants Pain · Moderate	2 Participants	1 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants Pain · Severe	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants Pain · Not Reported	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants Erythema · None	31 Participants	43 Participants	10 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants Erythema · Mild	3 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants Erythema · Moderate	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants Erythema · Severe	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants Erythema · Not Reported	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants Induration · Moderate	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants Pruritus · Mild	1 Participants	2 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants Pruritus · Moderate	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants Pruritus · Not Reported	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants Ecchymosis · Mild	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants Ecchymosis · Moderate	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants Ecchymosis · Severe	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants Ecchymosis · Not Reported	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants Tenderness · None	20 Participants	28 Participants	10 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants Tenderness · Mild	13 Participants	14 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants Tenderness · Moderate	1 Participants	1 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants Tenderness · Severe	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seronegative Participants Tenderness · Not Reported	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 29 through Day 36

Population: The Safety Analysis population includes all baseline ZIKV seronegative participants with available results who received at least one study vaccination.

The following injection site reactogenicity events were measured: pain, tenderness, pruritus, ecchymosis, erythema, and induration. Participants who reported not having a symptom are listed as "None", while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as "Not Reported". Severity is the maximum severity reported over all solicited symptoms post dosing for each participant.

Outcome measures

Outcome measures
Measure	2.5 mcg ZPIV n=31 Participants 2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.	5 mcg ZPIV n=41 Participants 5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.	Placebo n=9 Participants Placebo administered intramuscularly on Day 1 and Day 29.
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants Erythema · None	30 Participants	41 Participants	9 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants Erythema · Severe	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants Pruritus · Mild	2 Participants	1 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants Pruritus · Severe	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants Pruritus · Not Reported	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants Ecchymosis · Mild	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants Ecchymosis · Severe	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants Ecchymosis · Not Reported	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants Tenderness · Moderate	0 Participants	3 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants Tenderness · Not Reported	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants Any Local Symptom · None	17 Participants	32 Participants	9 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants Any Local Symptom · Mild	14 Participants	6 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants Any Local Symptom · Moderate	0 Participants	3 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants Any Local Symptom · Severe	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants Any Local Symptom · Not Reported	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants Pain · None	20 Participants	34 Participants	9 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants Pain · Mild	11 Participants	4 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants Pain · Moderate	0 Participants	3 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants Pain · Severe	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants Pain · Not Reported	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants Erythema · Mild	1 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants Erythema · Moderate	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants Erythema · Not Reported	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants Induration · None	30 Participants	41 Participants	9 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants Induration · Mild	1 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants Induration · Moderate	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants Induration · Severe	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants Induration · Not Reported	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants Pruritus · None	29 Participants	40 Participants	9 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants Pruritus · Moderate	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants Ecchymosis · None	31 Participants	41 Participants	9 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants Ecchymosis · Moderate	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants Tenderness · None	25 Participants	33 Participants	9 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants Tenderness · Mild	6 Participants	5 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seronegative Participants Tenderness · Severe	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 1 through Day 8

Population: The Safety Analysis population includes all baseline ZIKV seropositive and DENV seropositive participants who received at least one study vaccination.

The following injection site reactogenicity events were measured: pain, tenderness, pruritus, ecchymosis, erythema, and induration. Participants who reported not having a symptom are listed as "None", while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as "Not Reported". Severity is the maximum severity reported over all solicited symptoms post dosing for each participant.

Outcome measures

Outcome measures
Measure	2.5 mcg ZPIV n=1 Participants 2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.	5 mcg ZPIV n=1 Participants 5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.	Placebo Placebo administered intramuscularly on Day 1 and Day 29.
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Any Local Symptom · None	0 Participants	1 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Any Local Symptom · Severe	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Pain · None	0 Participants	1 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Pain · Mild	1 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Pain · Moderate	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Pain · Severe	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Pain · Not Reported	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Erythema · None	1 Participants	1 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Erythema · Severe	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Erythema · Not Reported	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Ecchymosis · None	1 Participants	1 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Ecchymosis · Moderate	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Ecchymosis · Severe	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Tenderness · Mild	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Tenderness · Moderate	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Tenderness · Severe	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Tenderness · Not Reported	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Any Local Symptom · Not Reported	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Any Local Symptom · Mild	1 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Any Local Symptom · Moderate	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Erythema · Mild	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Erythema · Moderate	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Induration · None	1 Participants	1 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Induration · Mild	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Induration · Moderate	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Induration · Severe	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Induration · Not Reported	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Pruritus · None	1 Participants	1 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Pruritus · Mild	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Pruritus · Moderate	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Pruritus · Severe	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Pruritus · Not Reported	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Ecchymosis · Mild	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Ecchymosis · Not Reported	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 1 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Tenderness · None	1 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 29 through Day 36

Population: The Safety Analysis population includes all baseline ZIKV seropositive and DENV seropositive participants with available results who received at least one study vaccination.

The following injection site reactogenicity events were measured: pain, tenderness, pruritus, ecchymosis, erythema, and induration. Participants who reported not having a symptom are listed as "None", while participants who did not complete their Memory Aid or could not remember whether they had a symptom are listed as "Not Reported". Severity is the maximum severity reported over all solicited symptoms post dosing for each participant.

Outcome measures

Outcome measures
Measure	2.5 mcg ZPIV n=1 Participants 2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.	5 mcg ZPIV n=1 Participants 5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.	Placebo Placebo administered intramuscularly on Day 1 and Day 29.
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Any Local Symptom · None	0 Participants	1 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Any Local Symptom · Mild	1 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Pain · None	0 Participants	1 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Pain · Moderate	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Erythema · Mild	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Erythema · Moderate	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Erythema · Severe	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Induration · Mild	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Induration · Moderate	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Ecchymosis · Moderate	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Tenderness · Mild	1 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Tenderness · Moderate	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Tenderness · Severe	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Tenderness · Not Reported	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Any Local Symptom · Moderate	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Any Local Symptom · Severe	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Any Local Symptom · Not Reported	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Pain · Mild	1 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Pain · Severe	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Pain · Not Reported	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Erythema · None	1 Participants	1 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Erythema · Not Reported	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Induration · None	1 Participants	1 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Induration · Severe	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Induration · Not Reported	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Pruritus · None	1 Participants	1 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Pruritus · Mild	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Pruritus · Moderate	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Pruritus · Severe	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Pruritus · Not Reported	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Ecchymosis · None	1 Participants	1 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Ecchymosis · Mild	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Ecchymosis · Severe	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Ecchymosis · Not Reported	0 Participants	0 Participants	0 Participants
Frequency and Severity of Solicited Local Events Post Dose 2 by Treatment Group for Baseline ZIKV Seropositive and DENV Seropositive Participants Tenderness · None	0 Participants	1 Participants	0 Participants

Adverse Events

2.5 mcg ZPIV

Serious events: 2 serious events

Other events: 20 other events

Deaths: 0 deaths

5 mcg ZPIV

Serious events: 1 serious events

Other events: 29 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 5 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	2.5 mcg ZPIV n=35 participants at risk 2.5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.	5 mcg ZPIV n=45 participants at risk 5 mcg ZPIV administered intramuscularly in a homologous prime-boost regimen on Day 1 and Day 29.	Placebo n=10 participants at risk Placebo administered intramuscularly on Day 1 and Day 29.
Infections and infestations Appendicitis	2.9% 1/35 • Number of events 1 • Solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. New-onset chronic medical conditions, Serious AEs and Adverse Events of Special Interest (AESIs) were collected from the time of first study vaccination through end of study follow up period (approximately 24 months). Solicited AEs included local reactions and systemic reactions. Local (injection site) reactions included pain, tenderness, pruritus, ecchymosis, erythema, and induration/swelling. Systemic reactions included fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, nausea, vomiting, diarrhea, abdominal pain, and rash.	0.00% 0/45 • Solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. New-onset chronic medical conditions, Serious AEs and Adverse Events of Special Interest (AESIs) were collected from the time of first study vaccination through end of study follow up period (approximately 24 months). Solicited AEs included local reactions and systemic reactions. Local (injection site) reactions included pain, tenderness, pruritus, ecchymosis, erythema, and induration/swelling. Systemic reactions included fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, nausea, vomiting, diarrhea, abdominal pain, and rash.	0.00% 0/10 • Solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. New-onset chronic medical conditions, Serious AEs and Adverse Events of Special Interest (AESIs) were collected from the time of first study vaccination through end of study follow up period (approximately 24 months). Solicited AEs included local reactions and systemic reactions. Local (injection site) reactions included pain, tenderness, pruritus, ecchymosis, erythema, and induration/swelling. Systemic reactions included fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, nausea, vomiting, diarrhea, abdominal pain, and rash.
Injury, poisoning and procedural complications Overdose	0.00% 0/35 • Solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. New-onset chronic medical conditions, Serious AEs and Adverse Events of Special Interest (AESIs) were collected from the time of first study vaccination through end of study follow up period (approximately 24 months). Solicited AEs included local reactions and systemic reactions. Local (injection site) reactions included pain, tenderness, pruritus, ecchymosis, erythema, and induration/swelling. Systemic reactions included fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, nausea, vomiting, diarrhea, abdominal pain, and rash.	0.00% 0/45 • Solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. New-onset chronic medical conditions, Serious AEs and Adverse Events of Special Interest (AESIs) were collected from the time of first study vaccination through end of study follow up period (approximately 24 months). Solicited AEs included local reactions and systemic reactions. Local (injection site) reactions included pain, tenderness, pruritus, ecchymosis, erythema, and induration/swelling. Systemic reactions included fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, nausea, vomiting, diarrhea, abdominal pain, and rash.	10.0% 1/10 • Number of events 1 • Solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. New-onset chronic medical conditions, Serious AEs and Adverse Events of Special Interest (AESIs) were collected from the time of first study vaccination through end of study follow up period (approximately 24 months). Solicited AEs included local reactions and systemic reactions. Local (injection site) reactions included pain, tenderness, pruritus, ecchymosis, erythema, and induration/swelling. Systemic reactions included fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, nausea, vomiting, diarrhea, abdominal pain, and rash.
Injury, poisoning and procedural complications Toxicity to various agents	2.9% 1/35 • Number of events 1 • Solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. New-onset chronic medical conditions, Serious AEs and Adverse Events of Special Interest (AESIs) were collected from the time of first study vaccination through end of study follow up period (approximately 24 months). Solicited AEs included local reactions and systemic reactions. Local (injection site) reactions included pain, tenderness, pruritus, ecchymosis, erythema, and induration/swelling. Systemic reactions included fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, nausea, vomiting, diarrhea, abdominal pain, and rash.	0.00% 0/45 • Solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. New-onset chronic medical conditions, Serious AEs and Adverse Events of Special Interest (AESIs) were collected from the time of first study vaccination through end of study follow up period (approximately 24 months). Solicited AEs included local reactions and systemic reactions. Local (injection site) reactions included pain, tenderness, pruritus, ecchymosis, erythema, and induration/swelling. Systemic reactions included fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, nausea, vomiting, diarrhea, abdominal pain, and rash.	0.00% 0/10 • Solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. New-onset chronic medical conditions, Serious AEs and Adverse Events of Special Interest (AESIs) were collected from the time of first study vaccination through end of study follow up period (approximately 24 months). Solicited AEs included local reactions and systemic reactions. Local (injection site) reactions included pain, tenderness, pruritus, ecchymosis, erythema, and induration/swelling. Systemic reactions included fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, nausea, vomiting, diarrhea, abdominal pain, and rash.
Psychiatric disorders Major depression	2.9% 1/35 • Number of events 1 • Solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. New-onset chronic medical conditions, Serious AEs and Adverse Events of Special Interest (AESIs) were collected from the time of first study vaccination through end of study follow up period (approximately 24 months). Solicited AEs included local reactions and systemic reactions. Local (injection site) reactions included pain, tenderness, pruritus, ecchymosis, erythema, and induration/swelling. Systemic reactions included fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, nausea, vomiting, diarrhea, abdominal pain, and rash.	0.00% 0/45 • Solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. New-onset chronic medical conditions, Serious AEs and Adverse Events of Special Interest (AESIs) were collected from the time of first study vaccination through end of study follow up period (approximately 24 months). Solicited AEs included local reactions and systemic reactions. Local (injection site) reactions included pain, tenderness, pruritus, ecchymosis, erythema, and induration/swelling. Systemic reactions included fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, nausea, vomiting, diarrhea, abdominal pain, and rash.	0.00% 0/10 • Solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. New-onset chronic medical conditions, Serious AEs and Adverse Events of Special Interest (AESIs) were collected from the time of first study vaccination through end of study follow up period (approximately 24 months). Solicited AEs included local reactions and systemic reactions. Local (injection site) reactions included pain, tenderness, pruritus, ecchymosis, erythema, and induration/swelling. Systemic reactions included fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, nausea, vomiting, diarrhea, abdominal pain, and rash.
Psychiatric disorders Schizoaffective disorder bipolar type	2.9% 1/35 • Number of events 1 • Solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. New-onset chronic medical conditions, Serious AEs and Adverse Events of Special Interest (AESIs) were collected from the time of first study vaccination through end of study follow up period (approximately 24 months). Solicited AEs included local reactions and systemic reactions. Local (injection site) reactions included pain, tenderness, pruritus, ecchymosis, erythema, and induration/swelling. Systemic reactions included fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, nausea, vomiting, diarrhea, abdominal pain, and rash.	0.00% 0/45 • Solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. New-onset chronic medical conditions, Serious AEs and Adverse Events of Special Interest (AESIs) were collected from the time of first study vaccination through end of study follow up period (approximately 24 months). Solicited AEs included local reactions and systemic reactions. Local (injection site) reactions included pain, tenderness, pruritus, ecchymosis, erythema, and induration/swelling. Systemic reactions included fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, nausea, vomiting, diarrhea, abdominal pain, and rash.	0.00% 0/10 • Solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. New-onset chronic medical conditions, Serious AEs and Adverse Events of Special Interest (AESIs) were collected from the time of first study vaccination through end of study follow up period (approximately 24 months). Solicited AEs included local reactions and systemic reactions. Local (injection site) reactions included pain, tenderness, pruritus, ecchymosis, erythema, and induration/swelling. Systemic reactions included fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, nausea, vomiting, diarrhea, abdominal pain, and rash.
Reproductive system and breast disorders Ovarian mass	0.00% 0/35 • Solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. New-onset chronic medical conditions, Serious AEs and Adverse Events of Special Interest (AESIs) were collected from the time of first study vaccination through end of study follow up period (approximately 24 months). Solicited AEs included local reactions and systemic reactions. Local (injection site) reactions included pain, tenderness, pruritus, ecchymosis, erythema, and induration/swelling. Systemic reactions included fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, nausea, vomiting, diarrhea, abdominal pain, and rash.	2.2% 1/45 • Number of events 1 • Solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. New-onset chronic medical conditions, Serious AEs and Adverse Events of Special Interest (AESIs) were collected from the time of first study vaccination through end of study follow up period (approximately 24 months). Solicited AEs included local reactions and systemic reactions. Local (injection site) reactions included pain, tenderness, pruritus, ecchymosis, erythema, and induration/swelling. Systemic reactions included fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, nausea, vomiting, diarrhea, abdominal pain, and rash.	0.00% 0/10 • Solicited Adverse Events (AEs) were collected from the time of each study vaccination through 8 days post-vaccination and unsolicited AEs were collected from the time of first study vaccination through 28 days after last study vaccination. New-onset chronic medical conditions, Serious AEs and Adverse Events of Special Interest (AESIs) were collected from the time of first study vaccination through end of study follow up period (approximately 24 months). Solicited AEs included local reactions and systemic reactions. Local (injection site) reactions included pain, tenderness, pruritus, ecchymosis, erythema, and induration/swelling. Systemic reactions included fever, feverishness, fatigue, malaise, myalgia, arthralgia, headache, nausea, vomiting, diarrhea, abdominal pain, and rash.

Other adverse events

Additional Information

Sarah George, MD

Saint Louis University

Phone: 314-977-9035

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60