Herpes Zoster, Herpes Zoster-related Complications
Conditions
Keywords
Prevention of herpes zoster and HZ-related complications
Brief summary
This study will evaluate the safety and immunogenicity of a heat-treated VZV vaccine in autologous or allogeneic hematopoietic cell transplant (HCT) recipients, human immunodeficiency virus (HIV)-infected participants with a baseline cluster of differentiation 4 (CD4) cell count ≤200 cells/mm\^3, participants with solid tumor malignancy (STM; breast, colorectal, lung, or ovarian malignancies) receiving chemotherapy, and participants with hematologic malignancy (HM; leukemia or leukemia-like disease, lymphoma or lymphoma-like disease, or multiple myeloma). The primary hypothesis is that the heat-treated VZV vaccine will elicit significant VZV-specific immune responses measured by either glycoprotein-based enzyme-linked immunosorbent assay (gpELISA) or VZV gamma interferon enzyme-linked immunospot (IFN-ELISPOT) at 28 days post dose vaccination 4 in, HIV-infected participants, participants with STM, and participants with HM. The primary immunogenicity objective and endpoints were considered by the protocol as exploratory for the autologous and allogeneic HCT groups.
Interventions
BIOLOGICALV212
0.65 ml V212 in 4 dose regimen. Treatment period of 125 days
BIOLOGICALPlacebo
0.65 ml V212 Pbo in 4 dose regimen. Treatment period of 125 days
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men and women \> or = to 18 years of age who are scheduled to receive an autologous or allogeneic hematopoietic cell transplant within 60 days of enrollment * HIV-infected participants with a baseline CD4 cell count \< or = to 200 cells/mm\^3 * Participants with hematologic malignancies; or participants who are receiving chemotherapy for breast, colorectal, lung, or ovarian malignancies
Exclusion criteria
* History of allergy to any vaccine component * Prior history of HZ * Prior history of receipt of any varicella or zoster vaccine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Fold Rise (GMFR) in Varicella-Zoster (VZV) Antibody Responses Measured by Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) | Baseline (Day 1 predose vaccination 1) and 28 days postdose 4 (~Day 118) | Blood sample taken at predose (Day 1) and 28 days post vaccination 4 to determine the geometric mean titre (GMT) of VZV antibodies via gpELISA. The GMFR was calculated as GMT Post-dose/GMT Pre-vaccination |
| Geometric Mean Fold Rise (GMFR) in Varicella-Zoster (VZV) Antibody Responses Measured by by VZV Interferon-gamma (IFN-g) Enzyme-linked Immunospot (ELISPOT) Assay | Baseline (Day 1 predose vaccination 1) and 28 days postdose 4 (~Day 118) | Blood sample taken at predose (Day 1) and 28 days post vaccination 4 to determine the geometric mean titre (GMT) of VZV antibodies via ELISPOT. The GMFR was calculated as GMT Post-dose/GMT Pre-vaccination |
| Percentage of Participants Who Experience at Least 1 Serious Adverse Event (SAE) | up to 28 days post vaccination 4 (up to ~Day 118) | An SAE was defined as an adverse event that resulted in death, was life threatening, resulted in persistent or significant disability or incapacity, resulted in or prolonged a hospitalization, is a congenital anomaly or birth defect, is a cancer, was an overdose, or was an important medical event based on appropriate medical judgment. The percentage of participants that experienced at least 1 SAE was summarized. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With an Injection-site Adverse Event Prompted on the Vaccination Report Card (VRC) | Up to Day 5 post any vaccination | An adverse event (AE) was defined as any untoward medical occurrence in a participant which did not necessarily have a causal relationship with study drug. An AE could therefore have been any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the study drug or protocol-specified procedure was also an AE. The percentage of participants with an injection-site AE prompted on the VRC was summarized. |
| Percentage of Participants With a Systemic Adverse Event Prompted on the VRC | Up to 28 days post vaccination 4 (up to ~118 days) | An adverse event (AE) was defined as any untoward medical occurrence in a participant which did not necessarily have a causal relationship with study drug. An AE could therefore have been any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the study drug or protocol-specified procedure was also an AE. The percentage of participants with a VRC-prompted systemic (non-injection site) AE was summarized. |
| Percentage of Participants With Elevated Oral Temperature (≥101.0°F (≥38.3ºC) Prompted on the VRC | Up to 28 days post any vaccination (up to ~118 days) | Participants were instructed on the VRC to take and record their oral (or oral equivalent) temperature daily from the day of vaccination from the date of each vaccine dose through the day prior to the next dose, or for 28 days. Elevated temperature was defined as ≥101.0°F (≥38.3ºC). The percentage of participants that record an elevated temperature was summarized. |
Participant flow
Recruitment details
Autologous or allogeneic hematopoietic cell transplant (HCT) recipients, human immunodeficiency virus (HIV)-infected participants, participants with solid tumor malignancy (STM) and receiving chemotherapy, and participants with hematologic malignancy (HM) were enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| Autologous HCT-V212 Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose. | 40 |
| Autologous HCT-Placebo Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose. | 10 |
| Allogeneic HCT-V212 Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose. | 41 |
| Allogeneic HCT-Placebo Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose. | 10 |
| STM-V212 Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose. | 59 |
| STM-Placebo Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose. | 20 |
| HM-V212 Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose. | 62 |
| HM-Placebo Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose. | 19 |
| HIV-V212 Participants receive V212 as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose. | 60 |
| HIV-Placebo Participants receive placebo as a 0.65 mL subcutaneous injection in a four-dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose. | 20 |
| Total | 341 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 9 | 3 | 3 | 0 | 5 | 1 | 2 | 1 |
| Overall Study | Lost to Follow-up | 1 | 2 | 0 | 0 | 2 | 0 | 0 | 0 | 6 | 1 |
| Overall Study | Physician Decision | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 2 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 0 | 2 | 1 | 6 | 1 | 5 | 0 | 4 | 2 |
Baseline characteristics
| Characteristic | Autologous HCT-V212 | Autologous HCT-Placebo | Allogeneic HCT-V212 | Allogeneic HCT-Placebo | STM-V212 | STM-Placebo | HM-V212 | HM-Placebo | HIV-V212 | HIV-Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized 18 to 49 years | 18 Participants | 6 Participants | 27 Participants | 4 Participants | 19 Participants | 3 Participants | 7 Participants | 4 Participants | 40 Participants | 14 Participants | 142 Participants |
| Age, Customized 50 to 59 years | 12 Participants | 1 Participants | 8 Participants | 3 Participants | 17 Participants | 4 Participants | 12 Participants | 3 Participants | 17 Participants | 6 Participants | 83 Participants |
| Age, Customized 60 to 69 years | 9 Participants | 3 Participants | 5 Participants | 2 Participants | 17 Participants | 4 Participants | 18 Participants | 6 Participants | 3 Participants | 0 Participants | 67 Participants |
| Age, Customized 70 to 79 years | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 5 Participants | 6 Participants | 19 Participants | 2 Participants | 0 Participants | 0 Participants | 35 Participants |
| Age, Customized ≥ 80 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 3 Participants | 6 Participants | 4 Participants | 0 Participants | 0 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 2 Participants | 7 Participants | 1 Participants | 8 Participants | 2 Participants | 5 Participants | 1 Participants | 8 Participants | 3 Participants | 41 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 36 Participants | 8 Participants | 34 Participants | 9 Participants | 51 Participants | 18 Participants | 57 Participants | 18 Participants | 52 Participants | 17 Participants | 300 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 4 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 9 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 5 Participants | 0 Participants | 20 Participants | 7 Participants | 6 Participants | 2 Participants | 38 Participants | 11 Participants | 91 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 36 Participants | 9 Participants | 36 Participants | 10 Participants | 35 Participants | 13 Participants | 55 Participants | 16 Participants | 21 Participants | 9 Participants | 240 Participants |
| Sex: Female, Male Female | 16 Participants | 3 Participants | 14 Participants | 1 Participants | 40 Participants | 15 Participants | 23 Participants | 8 Participants | 11 Participants | 4 Participants | 135 Participants |
| Sex: Female, Male Male | 24 Participants | 7 Participants | 27 Participants | 9 Participants | 19 Participants | 5 Participants | 39 Participants | 11 Participants | 49 Participants | 16 Participants | 206 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 40 | 0 / 10 | 11 / 40 | 2 / 10 | 1 / 57 | 0 / 19 | 4 / 61 | 0 / 19 | 1 / 60 | 0 / 20 |
| other Total, other adverse events | 40 / 40 | 10 / 10 | 40 / 40 | 9 / 10 | 38 / 57 | 13 / 19 | 51 / 61 | 10 / 19 | 33 / 60 | 12 / 20 |
| serious Total, serious adverse events | 13 / 40 | 2 / 10 | 32 / 40 | 7 / 10 | 7 / 57 | 2 / 19 | 12 / 61 | 1 / 19 | 8 / 60 | 2 / 20 |
Outcome results
Primary
Geometric Mean Fold Rise (GMFR) in Varicella-Zoster (VZV) Antibody Responses Measured by by VZV Interferon-gamma (IFN-g) Enzyme-linked Immunospot (ELISPOT) Assay
Blood sample taken at predose (Day 1) and 28 days post vaccination 4 to determine the geometric mean titre (GMT) of VZV antibodies via ELISPOT. The GMFR was calculated as GMT Post-dose/GMT Pre-vaccination
Time frame: Baseline (Day 1 predose vaccination 1) and 28 days postdose 4 (~Day 118)
Population: All randomised participants in STM, HM and HIV arms who had received at least 1 dose of V212, had at least 1 valid immunogenicity evaluation for VZV antibody and had post-vaccination IFN-g data available for endpoint. As per the protocol, immunogenicity results for the autologous and allogeneic HCT groups were considered exploratory.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| STM-V212 | Geometric Mean Fold Rise (GMFR) in Varicella-Zoster (VZV) Antibody Responses Measured by by VZV Interferon-gamma (IFN-g) Enzyme-linked Immunospot (ELISPOT) Assay | 3.00 Ratio |
| HM-V212 | Geometric Mean Fold Rise (GMFR) in Varicella-Zoster (VZV) Antibody Responses Measured by by VZV Interferon-gamma (IFN-g) Enzyme-linked Immunospot (ELISPOT) Assay | 2.23 Ratio |
| HIV-V212 | Geometric Mean Fold Rise (GMFR) in Varicella-Zoster (VZV) Antibody Responses Measured by by VZV Interferon-gamma (IFN-g) Enzyme-linked Immunospot (ELISPOT) Assay | 1.76 Ratio |
p-value: <0.001Single longitudinal regression model
p-value: 0.004Single longitudinal regression model
p-value: 0.026Single longitudinal regression model
Primary
Geometric Mean Fold Rise (GMFR) in Varicella-Zoster (VZV) Antibody Responses Measured by Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA)
Blood sample taken at predose (Day 1) and 28 days post vaccination 4 to determine the geometric mean titre (GMT) of VZV antibodies via gpELISA. The GMFR was calculated as GMT Post-dose/GMT Pre-vaccination
Time frame: Baseline (Day 1 predose vaccination 1) and 28 days postdose 4 (~Day 118)
Population: All randomised participants in STM, HM and HIV arms who had received at least 1 dose of V212, had at least 1 valid immunogenicity evaluation for VZV antibody and had post-vaccination gpELISA data available for endpoint. As per the protocol, immunogenicity results for the autologous and allogeneic HCT groups were considered exploratory.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| STM-V212 | Geometric Mean Fold Rise (GMFR) in Varicella-Zoster (VZV) Antibody Responses Measured by Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) | 2.35 Ratio |
| HM-V212 | Geometric Mean Fold Rise (GMFR) in Varicella-Zoster (VZV) Antibody Responses Measured by Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) | 1.28 Ratio |
| HIV-V212 | Geometric Mean Fold Rise (GMFR) in Varicella-Zoster (VZV) Antibody Responses Measured by Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) | 1.37 Ratio |
p-value: <0.001Single longitudinal regression model
p-value: 0.003Single longitudinal regression model
p-value: 0.017Single longitudinal regression model
Primary
Percentage of Participants Who Experience at Least 1 Serious Adverse Event (SAE)
An SAE was defined as an adverse event that resulted in death, was life threatening, resulted in persistent or significant disability or incapacity, resulted in or prolonged a hospitalization, is a congenital anomaly or birth defect, is a cancer, was an overdose, or was an important medical event based on appropriate medical judgment. The percentage of participants that experienced at least 1 SAE was summarized.
Time frame: up to 28 days post vaccination 4 (up to ~Day 118)
Population: All enrolled participants that received at least 1 dose of V212 or placebo and had available follow-up data for endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| STM-V212 | Percentage of Participants Who Experience at Least 1 Serious Adverse Event (SAE) | 32.5 Percentage of Participants |
| HM-V212 | Percentage of Participants Who Experience at Least 1 Serious Adverse Event (SAE) | 20.0 Percentage of Participants |
| HIV-V212 | Percentage of Participants Who Experience at Least 1 Serious Adverse Event (SAE) | 80.0 Percentage of Participants |
| Allogeneic HCT-Placebo | Percentage of Participants Who Experience at Least 1 Serious Adverse Event (SAE) | 70.0 Percentage of Participants |
| STM-V212 | Percentage of Participants Who Experience at Least 1 Serious Adverse Event (SAE) | 12.3 Percentage of Participants |
| STM-Placebo | Percentage of Participants Who Experience at Least 1 Serious Adverse Event (SAE) | 10.5 Percentage of Participants |
| HM-V212 | Percentage of Participants Who Experience at Least 1 Serious Adverse Event (SAE) | 19.7 Percentage of Participants |
| HM-Placebo | Percentage of Participants Who Experience at Least 1 Serious Adverse Event (SAE) | 5.3 Percentage of Participants |
| HIV-V212 | Percentage of Participants Who Experience at Least 1 Serious Adverse Event (SAE) | 13.3 Percentage of Participants |
| HIV-Placebo | Percentage of Participants Who Experience at Least 1 Serious Adverse Event (SAE) | 10.0 Percentage of Participants |
95% CI: [-21.7, 35.3]
95% CI: [-15.1, 42.9]
95% CI: [-20.4, 15.7]
95% CI: [-6.5, 27.6]
95% CI: [-18.1, 17]
Secondary
Percentage of Participants With an Injection-site Adverse Event Prompted on the Vaccination Report Card (VRC)
An adverse event (AE) was defined as any untoward medical occurrence in a participant which did not necessarily have a causal relationship with study drug. An AE could therefore have been any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the study drug or protocol-specified procedure was also an AE. The percentage of participants with an injection-site AE prompted on the VRC was summarized.
Time frame: Up to Day 5 post any vaccination
Population: All enrolled participants that received at least 1 dose of V212 or placebo and had available follow-up data for endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| STM-V212 | Percentage of Participants With an Injection-site Adverse Event Prompted on the Vaccination Report Card (VRC) | 10.0 Percentage of Participants |
| HM-V212 | Percentage of Participants With an Injection-site Adverse Event Prompted on the Vaccination Report Card (VRC) | 10.0 Percentage of Participants |
| HIV-V212 | Percentage of Participants With an Injection-site Adverse Event Prompted on the Vaccination Report Card (VRC) | 10.0 Percentage of Participants |
| Allogeneic HCT-Placebo | Percentage of Participants With an Injection-site Adverse Event Prompted on the Vaccination Report Card (VRC) | 0.0 Percentage of Participants |
| STM-V212 | Percentage of Participants With an Injection-site Adverse Event Prompted on the Vaccination Report Card (VRC) | 36.8 Percentage of Participants |
| STM-Placebo | Percentage of Participants With an Injection-site Adverse Event Prompted on the Vaccination Report Card (VRC) | 5.3 Percentage of Participants |
| HM-V212 | Percentage of Participants With an Injection-site Adverse Event Prompted on the Vaccination Report Card (VRC) | 31.1 Percentage of Participants |
| HM-Placebo | Percentage of Participants With an Injection-site Adverse Event Prompted on the Vaccination Report Card (VRC) | 10.5 Percentage of Participants |
| HIV-V212 | Percentage of Participants With an Injection-site Adverse Event Prompted on the Vaccination Report Card (VRC) | 3.3 Percentage of Participants |
| HIV-Placebo | Percentage of Participants With an Injection-site Adverse Event Prompted on the Vaccination Report Card (VRC) | 15.0 Percentage of Participants |
p-value: >0.99995% CI: [-31.7, 16.5]Asymptotic method
p-value: 0.30295% CI: [-18.8, 23.2]Asymptotic method
p-value: 0.00995% CI: [9.7, 46.2]Asymptotic method
p-value: 0.04195% CI: [1.3, 36.6]Asymptotic method
p-value: 0.06495% CI: [-33.2, 0.6]Asymptotic method
Secondary
Percentage of Participants With a Systemic Adverse Event Prompted on the VRC
An adverse event (AE) was defined as any untoward medical occurrence in a participant which did not necessarily have a causal relationship with study drug. An AE could therefore have been any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the study drug or protocol-specified procedure was also an AE. The percentage of participants with a VRC-prompted systemic (non-injection site) AE was summarized.
Time frame: Up to 28 days post vaccination 4 (up to ~118 days)
Population: All enrolled participants that received at least 1 dose of V212 or placebo and had available follow-up data for endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| STM-V212 | Percentage of Participants With a Systemic Adverse Event Prompted on the VRC | 5.0 Percentage of Participants |
| HM-V212 | Percentage of Participants With a Systemic Adverse Event Prompted on the VRC | 10.0 Percentage of Participants |
| HIV-V212 | Percentage of Participants With a Systemic Adverse Event Prompted on the VRC | 2.5 Percentage of Participants |
| Allogeneic HCT-Placebo | Percentage of Participants With a Systemic Adverse Event Prompted on the VRC | 0.0 Percentage of Participants |
| STM-V212 | Percentage of Participants With a Systemic Adverse Event Prompted on the VRC | 3.5 Percentage of Participants |
| STM-Placebo | Percentage of Participants With a Systemic Adverse Event Prompted on the VRC | 0.0 Percentage of Participants |
| HM-V212 | Percentage of Participants With a Systemic Adverse Event Prompted on the VRC | 4.9 Percentage of Participants |
| HM-Placebo | Percentage of Participants With a Systemic Adverse Event Prompted on the VRC | 0.0 Percentage of Participants |
| HIV-V212 | Percentage of Participants With a Systemic Adverse Event Prompted on the VRC | 5.0 Percentage of Participants |
| HIV-Placebo | Percentage of Participants With a Systemic Adverse Event Prompted on the VRC | 5.0 Percentage of Participants |
p-value: 0.55695% CI: [-36.3, 9.5]Asymptotic method
p-value: 0.61795% CI: [-25.8, 13]Asymptotic method
p-value: 0.41195% CI: [-13.7, 12]Asymptotic method
p-value: 0.32895% CI: [-12.3, 13.6]Asymptotic method
p-value: >0.99995% CI: [-19.2, 10]Asymptotic method
Secondary
Percentage of Participants With Elevated Oral Temperature (≥101.0°F (≥38.3ºC) Prompted on the VRC
Participants were instructed on the VRC to take and record their oral (or oral equivalent) temperature daily from the day of vaccination from the date of each vaccine dose through the day prior to the next dose, or for 28 days. Elevated temperature was defined as ≥101.0°F (≥38.3ºC). The percentage of participants that record an elevated temperature was summarized.
Time frame: Up to 28 days post any vaccination (up to ~118 days)
Population: All enrolled participants that received at least 1 dose of V212 or placebo and had available follow-up data for endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| STM-V212 | Percentage of Participants With Elevated Oral Temperature (≥101.0°F (≥38.3ºC) Prompted on the VRC | 60.5 Percentage of Participants |
| HM-V212 | Percentage of Participants With Elevated Oral Temperature (≥101.0°F (≥38.3ºC) Prompted on the VRC | 50.0 Percentage of Participants |
| HIV-V212 | Percentage of Participants With Elevated Oral Temperature (≥101.0°F (≥38.3ºC) Prompted on the VRC | 66.7 Percentage of Participants |
| Allogeneic HCT-Placebo | Percentage of Participants With Elevated Oral Temperature (≥101.0°F (≥38.3ºC) Prompted on the VRC | 60.0 Percentage of Participants |
| STM-V212 | Percentage of Participants With Elevated Oral Temperature (≥101.0°F (≥38.3ºC) Prompted on the VRC | 7.5 Percentage of Participants |
| STM-Placebo | Percentage of Participants With Elevated Oral Temperature (≥101.0°F (≥38.3ºC) Prompted on the VRC | 0.0 Percentage of Participants |
| HM-V212 | Percentage of Participants With Elevated Oral Temperature (≥101.0°F (≥38.3ºC) Prompted on the VRC | 12.1 Percentage of Participants |
| HM-Placebo | Percentage of Participants With Elevated Oral Temperature (≥101.0°F (≥38.3ºC) Prompted on the VRC | 5.3 Percentage of Participants |
| HIV-V212 | Percentage of Participants With Elevated Oral Temperature (≥101.0°F (≥38.3ºC) Prompted on the VRC | 14.3 Percentage of Participants |
| HIV-Placebo | Percentage of Participants With Elevated Oral Temperature (≥101.0°F (≥38.3ºC) Prompted on the VRC | 10.5 Percentage of Participants |
p-value: 0.55295% CI: [-21.3, 41.8]Asymptotic method
p-value: 0.69695% CI: [-22.5, 39.4]Asymptotic method
p-value: 0.22195% CI: [-9.8, 18]Asymptotic method
p-value: 0.40295% CI: [-13.7, 19.1]Asymptotic method
p-value: 0.67995% CI: [-18.5, 18.2]Asymptotic method