Trial Outcomes & Findings for Safety and Therapeutic Efficacy of the VRC01 Antibody in Patients Who Initiated Antiretroviral Therapy During Early Acute HIV Infection (NCT NCT02664415)

NCT ID: NCT02664415

Last Updated: 2021-11-02

Results Overview

Participants were monitored for up to 10 weeks after the last infusion of VRC01 or placebo

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

23 participants

Primary outcome timeframe

Measured up to 10 weeks after last infusion of VRC01 or placebo

Results posted on

2021-11-02

Participant Flow

This study was conducted at the Thai Red Cross AIDS Research Centre in Bangkok, Thailand. Participants were recruited between 9 August 2016 and 9 January 2017, from ongoing Acute HIV Infection (AHI) cohorts and received ART during AHI via a separately-funded protocol (clinicaltrials.gov NCT00796263).

Twenty-three participants were enrolled, 4 were withdrawn prior to randomization because of the unavailability of study product in-country, and 19 were randomized with 5 assigned to placebo and 14 to VRC01. One VRC01 recipient experienced severe generalized urticaria during the first study infusion and did not complete the study.

Participant milestones

Participant milestones
Measure	VRC01 Participants will receive an intravenous (IV) infusion of 40 mg/kg of VRC01 at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met. VRC01: 40 mg/kg; administered IV	Placebo for VRC01 Participants will receive an IV infusion of placebo at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met. Placebo for VRC01: Sodium Chloride for Injection 0.9%, USP; administered IV
Overall Study STARTED	14	5
Overall Study COMPLETED	13	5
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	VRC01 Participants will receive an intravenous (IV) infusion of 40 mg/kg of VRC01 at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met. VRC01: 40 mg/kg; administered IV	Placebo for VRC01 Participants will receive an IV infusion of placebo at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met. Placebo for VRC01: Sodium Chloride for Injection 0.9%, USP; administered IV
Overall Study Adverse Event	1	0

Baseline Characteristics

Safety and Therapeutic Efficacy of the VRC01 Antibody in Patients Who Initiated Antiretroviral Therapy During Early Acute HIV Infection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	VRC01 n=13 Participants Participants will receive an intravenous (IV) infusion of 40 mg/kg of VRC01 at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met. VRC01: 40 mg/kg; administered IV	Placebo for VRC01 n=5 Participants Participants will receive an IV infusion of placebo at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met. Placebo for VRC01: Sodium Chloride for Injection 0.9%, USP; administered IV	Total n=18 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants	5 Participants n=7 Participants	18 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	32 years n=5 Participants	25 years n=7 Participants	29 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	5 Participants n=7 Participants	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants	5 Participants n=7 Participants	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Thailand	13 Participants n=5 Participants	5 Participants n=7 Participants	18 Participants n=5 Participants
HIV-subtype CRF01_AE	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
HIV-subtype B	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
HIV-subtype CRF01_AE and B co-infection	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
HIV-subtype CRF01_AE/B/C recombinant	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Feibig stage at ART initiation I (RNA+, p24-)	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Feibig stage at ART initiation II (p24+, IgM-)	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Feibig stage at ART initiation III (IgM+, WB-)	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: Measured up to 10 weeks after last infusion of VRC01 or placebo

Population: Participants who were randomized to receive VRC01 or placebo.

Participants were monitored for up to 10 weeks after the last infusion of VRC01 or placebo

Outcome measures

Outcome measures
Measure	VRC01 n=14 Participants Participants will receive an intravenous (IV) infusion of 40 mg/kg of VRC01 at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met. VRC01: 40 mg/kg; administered IV	Placebo for VRC01 n=5 Participants Participants will receive an IV infusion of placebo at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met. Placebo for VRC01: Sodium Chloride for Injection 0.9%, USP; administered IV
Number of Participants With Serious Adverse Event	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Measured through 24 weeks after ATI

Population: This is the number of participants who received at least one full dose of VRC01 or placbo, underwent Analytic Treatment Interruption (ATI).

Number of participants who sustained virologic control (HIV RNA \<50 copies/mL), without indication for ART resumption at week 24.

Outcome measures

Outcome measures
Measure	VRC01 n=13 Participants Participants will receive an intravenous (IV) infusion of 40 mg/kg of VRC01 at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met. VRC01: 40 mg/kg; administered IV	Placebo for VRC01 n=5 Participants Participants will receive an IV infusion of placebo at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met. Placebo for VRC01: Sodium Chloride for Injection 0.9%, USP; administered IV
Number of Participants With Sustained Virologic Suppression	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Measured from Baseline ATI through ART resumption.

Population: Participants who received at least 1 full dose of VRC01 or Placebo and underwent ATI.

This is the days from Analytic Treatment Interruption (ATI) to: 1. HIV RNA \>= 20 copies/mL. 2. HIV RNA \>= 1000 copies/mL

Outcome measures

Outcome measures
Measure	VRC01 n=13 Participants Participants will receive an intravenous (IV) infusion of 40 mg/kg of VRC01 at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met. VRC01: 40 mg/kg; administered IV	Placebo for VRC01 n=5 Participants Participants will receive an IV infusion of placebo at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met. Placebo for VRC01: Sodium Chloride for Injection 0.9%, USP; administered IV
Time to Viral Rebound After Cessation of ART Time from ATI to HIV-1 RNA >= 20 copies/mL	29 days Interval 9.0 to 296.0	14 days Interval 14.0 to 29.0
Time to Viral Rebound After Cessation of ART Time from ATI to HIV-1 RNA >= 1000 copies/mL	33 days Interval 13.0 to 305.0	14 days Interval 14.0 to 32.0

SECONDARY outcome

Timeframe: Measured from Baseline ATI through ART resumption.

Population: Participants who received at least 1 full dose of VRC01 or Placebo and underwent ATI.

This is the HIV-1 RNA levels (copies/mL) at first detection and ART resumption.

Outcome measures

Outcome measures
Measure	VRC01 n=13 Participants Participants will receive an intravenous (IV) infusion of 40 mg/kg of VRC01 at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met. VRC01: 40 mg/kg; administered IV	Placebo for VRC01 n=5 Participants Participants will receive an IV infusion of placebo at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met. Placebo for VRC01: Sodium Chloride for Injection 0.9%, USP; administered IV
Level of Rebound Viremia After Cessation of ART HIV-1 RNA at ART resumption	3440 copies/mL Interval 1587.0 to 31807.0	3845 copies/mL Interval 1401.0 to 26865.0
Level of Rebound Viremia After Cessation of ART HIV-1 RNA at first detection	105 copies/mL Interval 21.0 to 900.0	1015 copies/mL Interval 229.0 to 7395.0

SECONDARY outcome

Timeframe: Measured from Baseline ATI through ART resumption.

Population: Participants who received at least one full dose of VRC01 or placebo and underwent ATI.

This is the days from ATI to ART resumptions.

Outcome measures

Outcome measures
Measure	VRC01 n=13 Participants Participants will receive an intravenous (IV) infusion of 40 mg/kg of VRC01 at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met. VRC01: 40 mg/kg; administered IV	Placebo for VRC01 n=5 Participants Participants will receive an IV infusion of placebo at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met. Placebo for VRC01: Sodium Chloride for Injection 0.9%, USP; administered IV
Time to ART Resumption for Any Reason After Cessation of ART	35 days Interval 14.0 to 309.0	23 days Interval 16.0 to 35.0

SECONDARY outcome

Timeframe: Measured from Baseline ATI through ART resumption.

Population: Participants who received at least 1 full dose of VRC01 or Placebo and underwent ATI.

This is number of participants who had detectable HIV-1 RNA via the ultrasensitive single copy assay prior to detectability on the routine assay.

Outcome measures

Outcome measures
Measure	VRC01 n=13 Participants Participants will receive an intravenous (IV) infusion of 40 mg/kg of VRC01 at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met. VRC01: 40 mg/kg; administered IV	Placebo for VRC01 n=5 Participants Participants will receive an IV infusion of placebo at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met. Placebo for VRC01: Sodium Chloride for Injection 0.9%, USP; administered IV
Number of Participants With Detectable HIV-1 RNA Via Single Copy Assay	8 Participants	3 Participants

SECONDARY outcome

Timeframe: Measured from Baseline ATI through ART resumption

Population: Participants who received at least 1 full dose of VRC01 or Placebo and underwent ATI.

This is change in CD4+ T cell count from ATI to ART resumption.

Outcome measures

Outcome measures
Measure	VRC01 n=13 Participants Participants will receive an intravenous (IV) infusion of 40 mg/kg of VRC01 at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met. VRC01: 40 mg/kg; administered IV	Placebo for VRC01 n=5 Participants Participants will receive an IV infusion of placebo at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met. Placebo for VRC01: Sodium Chloride for Injection 0.9%, USP; administered IV
Change in CD4+ T Cell Count From ATI to ART Resumption	-37 cells/mm^3 Interval -258.0 to 101.0	-21 cells/mm^3 Interval -248.0 to 258.0

SECONDARY outcome

Timeframe: Measured from ATI through 6 months after ART resumption

Population: Participants who received at least 1 full dose of VRC01 or Placebo and underwent ATI.

This is total HIV DNA levels at baseline ATI, ART resumption and 6 month after ART resumption

Outcome measures

Outcome measures
Measure	VRC01 n=13 Participants Participants will receive an intravenous (IV) infusion of 40 mg/kg of VRC01 at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met. VRC01: 40 mg/kg; administered IV	Placebo for VRC01 n=5 Participants Participants will receive an IV infusion of placebo at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met. Placebo for VRC01: Sodium Chloride for Injection 0.9%, USP; administered IV
Total HIV DNA in the Peripheral Compartment Total HIV DNA at baseline ATI	16 copies/10^6 CD4 T cells Interval 0.0 to 75.0	3 copies/10^6 CD4 T cells Interval 0.0 to 54.0
Total HIV DNA in the Peripheral Compartment Total HIV DNA at ART resumption	24 copies/10^6 CD4 T cells Interval 3.0 to 265.0	39 copies/10^6 CD4 T cells Interval 5.0 to 169.0
Total HIV DNA in the Peripheral Compartment Total HIV DNA at 6 months after ART resumption	9 copies/10^6 CD4 T cells Interval 0.0 to 56.0	15 copies/10^6 CD4 T cells Interval 0.0 to 60.0

SECONDARY outcome

Timeframe: Measured up to 10 weeks after the last infusion of VRC01 or placebo

Population: Participants who have been randomized to receive VRC01 or Placebo.

Participants were monitored for up to 10 weeks after the last infusion of VRC01 or placebo

Outcome measures

Outcome measures
Measure	VRC01 n=14 Participants Participants will receive an intravenous (IV) infusion of 40 mg/kg of VRC01 at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met. VRC01: 40 mg/kg; administered IV	Placebo for VRC01 n=5 Participants Participants will receive an IV infusion of placebo at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met. Placebo for VRC01: Sodium Chloride for Injection 0.9%, USP; administered IV
Number of Participants Hospitalized.	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Measured from Baseline ATI through ART resumption.

Population: Participants who received at least one full dose of VRC01 or Placebo and underwent treatment interruption.

This is the number of participants who have developed during ATI.

Outcome measures

Outcome measures
Measure	VRC01 n=13 Participants Participants will receive an intravenous (IV) infusion of 40 mg/kg of VRC01 at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met. VRC01: 40 mg/kg; administered IV	Placebo for VRC01 n=5 Participants Participants will receive an IV infusion of placebo at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met. Placebo for VRC01: Sodium Chloride for Injection 0.9%, USP; administered IV
Number of Participants With Acute Retroviral Syndrome (ARS)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Measured from Baseline ATI through ART resumption.

Population: Participants who received at least one full dose of VRC01 or Placebo and underwent ATI.

This is a NPZ-4 score,a 4-test NP battery evaluated fine motor function/manual dexterity \[Grooved Pegboard test (GP), non-dominant hand\], psychomotor speed \[Color Trails 1 (CT1), Trail Making A (TM)\], and executive function/set shifting \[Color Trails 2 (CT2)\]. Individual test raw scores were converted to z-scores. Z-scores range from -3 standard deviations up to +3 standard deviations. Higher scores indicate better test performance and lower cognitive impairment.

Outcome measures

Outcome measures
Measure	VRC01 n=13 Participants Participants will receive an intravenous (IV) infusion of 40 mg/kg of VRC01 at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met. VRC01: 40 mg/kg; administered IV	Placebo for VRC01 n=5 Participants Participants will receive an IV infusion of placebo at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met. Placebo for VRC01: Sodium Chloride for Injection 0.9%, USP; administered IV
Neuropsychological Battery Performance NPZ- at ART resumption	1.25 Z-score Interval 0.02 to 1.7	1.04 Z-score Interval 0.41 to 1.73
Neuropsychological Battery Performance NPZ-4 at baseline ATI	0.87 Z-score Interval 0.26 to 1.48	1.19 Z-score Interval 0.16 to 1.3

SECONDARY outcome

Timeframe: Measured from Baseline ATI through ART resumption.

Population: Participants who received at least 1 full dose of VRC01 or Placebo and underwent ATI.

The Flanker is a measure of executive function, specifically tapping inhibitory control and attention.The scores range from 0 to 10. A higher scores indicate higher levels of ability to attend to relevant stimuli and inhibit attention from irrelevant stimuli.

Outcome measures

Outcome measures
Measure	VRC01 n=13 Participants Participants will receive an intravenous (IV) infusion of 40 mg/kg of VRC01 at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met. VRC01: 40 mg/kg; administered IV	Placebo for VRC01 n=5 Participants Participants will receive an IV infusion of placebo at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met. Placebo for VRC01: Sodium Chloride for Injection 0.9%, USP; administered IV
Computed Score on the Control and Attention Task (i.e., Flanker Task) Baseline ATI	8.24 score Interval 7.43 to 9.23	8.36 score Interval 8.05 to 8.83
Computed Score on the Control and Attention Task (i.e., Flanker Task) ART resumption	8.4 score Interval 7.3 to 9.7	8.41 score Interval 7.46 to 9.18

Adverse Events

VRC01

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Placebo for VRC01

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Biostatistician

MHRP

Phone: 3015003715

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	VRC01 n=14 participants at risk Participants will receive an intravenous (IV) infusion of 40 mg/kg of VRC01 at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met. VRC01: 40 mg/kg; administered IV	Placebo for VRC01 n=5 participants at risk Participants will receive an IV infusion of placebo at Week 0 and every 3 weeks until Week 24 or until criteria for resumption of ART are met. Placebo for VRC01: Sodium Chloride for Injection 0.9%, USP; administered IV
General disorders Fatigue	50.0% 7/14 • Number of events 8 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.	60.0% 3/5 • Number of events 4 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.
Gastrointestinal disorders Nausea	35.7% 5/14 • Number of events 7 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.	20.0% 1/5 • Number of events 1 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.
Injury, poisoning and procedural complications Infusion site pain	21.4% 3/14 • Number of events 3 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.	40.0% 2/5 • Number of events 2 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.
Nervous system disorders Headche	28.6% 4/14 • Number of events 9 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.	80.0% 4/5 • Number of events 8 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.
Injury, poisoning and procedural complications Infusion site bruising	14.3% 2/14 • Number of events 2 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.	0.00% 0/5 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.
Musculoskeletal and connective tissue disorders Myalgia	28.6% 4/14 • Number of events 4 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.	0.00% 0/5 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.
Injury, poisoning and procedural complications Infusion site erythema	7.1% 1/14 • Number of events 1 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.	0.00% 0/5 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.
General disorders Generalized urticaria	7.1% 1/14 • Number of events 1 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.	0.00% 0/5 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.
Gastrointestinal disorders Diarrhea	14.3% 2/14 • Number of events 3 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.	20.0% 1/5 • Number of events 1 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.
Hepatobiliary disorders ALT increased	7.1% 1/14 • Number of events 1 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.	0.00% 0/5 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.
Gastrointestinal disorders Abdominal gas	0.00% 0/14 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.	20.0% 1/5 • Number of events 1 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.
Skin and subcutaneous tissue disorders Acne	14.3% 2/14 • Number of events 2 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.	0.00% 0/5 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.
Skin and subcutaneous tissue disorders Allergic dermatitis	7.1% 1/14 • Number of events 1 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.	0.00% 0/5 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.
Immune system disorders Allergy	7.1% 1/14 • Number of events 1 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.	0.00% 0/5 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.
Gastrointestinal disorders Aphthous mouth ulcer	7.1% 1/14 • Number of events 1 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.	0.00% 0/5 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.
Musculoskeletal and connective tissue disorders Arthralgia	7.1% 1/14 • Number of events 1 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.	0.00% 0/5 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.
Musculoskeletal and connective tissue disorders Back pain	7.1% 1/14 • Number of events 1 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.	0.00% 0/5 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.
General disorders Chills	7.1% 1/14 • Number of events 1 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.	0.00% 0/5 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.
Infections and infestations Chlamydia	0.00% 0/14 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.	20.0% 1/5 • Number of events 1 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.
Infections and infestations Common cold	7.1% 1/14 • Number of events 1 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.	20.0% 1/5 • Number of events 1 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.
Nervous system disorders Confusion	0.00% 0/14 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.	20.0% 1/5 • Number of events 1 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.
Respiratory, thoracic and mediastinal disorders Cough	14.3% 2/14 • Number of events 2 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.	20.0% 1/5 • Number of events 1 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.
Skin and subcutaneous tissue disorders Dermatitis of dorsum, both hands	7.1% 1/14 • Number of events 1 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.	0.00% 0/5 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.
Skin and subcutaneous tissue disorders Eczema	7.1% 1/14 • Number of events 1 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.	0.00% 0/5 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.
Injury, poisoning and procedural complications Hematoma	7.1% 1/14 • Number of events 1 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.	20.0% 1/5 • Number of events 1 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.
Metabolism and nutrition disorders Hyperlipidemia	14.3% 2/14 • Number of events 2 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.	20.0% 1/5 • Number of events 1 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.
Cardiac disorders Hypertension	7.1% 1/14 • Number of events 1 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.	0.00% 0/5 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.
Musculoskeletal and connective tissue disorders Joint pain	7.1% 1/14 • Number of events 1 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.	0.00% 0/5 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.
Gastrointestinal disorders Loose stool	14.3% 2/14 • Number of events 2 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.	0.00% 0/5 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.
Immune system disorders Lymphadenopathy, right cervical	7.1% 1/14 • Number of events 1 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.	0.00% 0/5 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.
Gastrointestinal disorders Mouth sore	0.00% 0/14 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.	20.0% 1/5 • Number of events 1 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.
Gastrointestinal disorders Oral ulcer	7.1% 1/14 • Number of events 1 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.	0.00% 0/5 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.
Musculoskeletal and connective tissue disorders Pain in extremity	7.1% 1/14 • Number of events 1 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.	0.00% 0/5 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.
Nervous system disorders Peripheral neuropathy	0.00% 0/14 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.	20.0% 1/5 • Number of events 1 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.
Gastrointestinal disorders Pharyngitis	14.3% 2/14 • Number of events 3 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.	0.00% 0/5 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.
Infections and infestations Syphilis	14.3% 2/14 • Number of events 2 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.	0.00% 0/5 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.
Infections and infestations Upper respiratory tract infection	14.3% 2/14 • Number of events 4 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.	20.0% 1/5 • Number of events 1 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.
Gastrointestinal disorders Vomiting	7.1% 1/14 • Number of events 2 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.	0.00% 0/5 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.
Gastrointestinal disorders Sore throat	7.1% 1/14 • Number of events 1 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.	20.0% 1/5 • Number of events 1 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.
Eye disorders Subconjunctival hematoma	7.1% 1/14 • Number of events 1 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.	0.00% 0/5 • Infusion-related and unrelated Adverse Events were collected during the first study agent administration through 175 days after the last study agent administration.