Phase 2 N=597 Tecovirimat for Treatment of Monkeypox Virus
Monkeypox
Primary: Time to Lesion Resolution — 7; 8 Days
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Phase 2 N=229 Trial to Evaluate the Immunogenicity of Dose Reduction Strategies of the MVA-BN Monkeypox Vaccine
Monkeypox
Primary: Vaccinia Virus Specific Plaque Reduction Neutralization Test (PRNT) Geometric Mean Titer (GMT) at Day 43 — 203.2; 113.2; 288.9 titer — p=0.045
Phase 4 N=22 Special Access Program IMVAMUNE®
Vaccination
Primary: ELISA Seropositivity Rate — 40.9; 100.0 percentage of subjects
Phase 2 N=91 High Dose IMVAMUNE® in Vaccinia-Naive Individuals
Smallpox
Primary: Time to Seroconversion After One Vaccination Using Bavarian Nordic's (BN) Enzyme Linked Immunosorbent Assay (ELISA) in the Intent-to-Treat (ITT) Population — 14; 14 days
Phase 2 N=581 Safety and Immunogenicity of IMVAMUNE® (MVA-BN®) Smallpox Vaccine in HIV Infected Patients
HIV Infections
Primary: Serious Adverse Events — 0; 17; 0; 6 Participants
Phase 2 N=526 A Phase 2 Randomized Multisite Trial to Inform Public Health Strategies Involving the Use of MVA-BN Vaccine for Mpox
Monkeypox
Primary: Vaccinia Virus Specific Plaque Reduction Neutralization Test (PRNT) Geometric Mean Titer (GMT) — 470.3; 295.7; 293.2 titer — p=<0.001
Phase 2 N=72 ACAM 3000 MVA at Harvard Medical School
Smallpox
Primary: Number of Participants Reporting Moderate or Greater Solicited Local Reactions — 3; 0; 1; 6 Participants
Phase 1 N=40 Ebola Sudan Chimpanzee Adenovirus Vector Vaccine in Healthy Adults
Ebola Virus
Primary: Number of Participants Reporting Local Reactogenicity Signs and Symptoms for 7 Days After the cAd3-EBO S Vaccine Administration — 3; 3; 6; 16 Participants
Phase 2 N=523 Lyophilized IMVAMUNE® (1x10^8 TCID50) Versus Liquid IMVAMUNE® (1x10^8 TCID50) Administered Subcutaneously and a Lower Dose Liquid IMVAMUNE® (2x10^7 TCID50) Administered Intradermally
Smallpox
Primary: Geometric Mean Titer (GMT) Based on Vaccinia-specific Individual Peak Plaque Reduction Neutralization Titers (PRNT) Following 2 Doses of IMVAMUNE® Lyophilized Versus…
Phase 2 N=435 Phase II Trial to Assess Safety and Immunogenicity of IMVAMUNE®
Smallpox
Primary: Geometric Mean Peak Plaque Reduction Neutralization Titer (PRNT) After Second Vaccination — 138.0; 55.1; 75.9; 103.5 titers
Phase 3 N=123 Safety and Efficacy of CJ-50300 in Healthy Volunteers
Smallpox
Primary: Cutaneous Take Reaction — 81; 41 participants
N/A N=300 Sylvatic Transmission of Zika, Dengue, and Chikungunya Viruses in Thailand and Cambodia
Dengue Fever · Zika · Vector-Borne Diseases
Primary: Assessment of DENV, ZIKV, CHIKV Seroprevalence Via Screening PRNT50 Titers in Cambodian Adults. — 300 Participants
Phase 2 N=353 Effect of Dose, Safety, Tolerability of a New Smallpox Vaccine in Adults Without Previous Smallpox Vaccination
Smallpox
Primary: Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine — 2; 4; 3; 4 Participants
Phase 2 N=226 MVA Post-Event: Administration Timing and Boost Study
Smallpox
Primary: Geometric Mean Titer (GMT) of Bavarian Nordic's (BN) Plaque Reduction Neutralizing Antibody Titer (PRNT) Assay in Groups A and B — 10.8; 30.2 titer
Phase 2 N=120 A Study to Evaluate Safety and Immunogenicity of One and Two Doses of IMVAMUNE® Smallpox Vaccine in 56-80 Year Old Vaccinia-experienced Subjects
Smallpox
Primary: Related Serious Adverse Events — 0; 0 Participants
Phase 3 N=4,005 A Trial to Evaluate Immunogenicity and Safety of Three Consecutive Production Lots of IMVAMUNE® (MVA-BN®) Smallpox Vaccine in Healthy, Vaccinia-naïve Subjects
Smallpox
Primary: PRNT GMT — 110.7; 100.5; 117.2; 1.0 Titer
Phase 2 N=632 A Phase II Study on Immunogenicity and Safety of MVA-BN® (IMVAMUNE™) Smallpox Vaccine in Subjects With Atopic Dermatitis
Atopic Dermatitis
Primary: Percentage of Participants With Seroconversion by ELISA — 98.5; 97.3 percentage of subjects
N/A N=2,000 Morbidity, Mortality And Risk Factors of Mpox in HIV Negative High Risk Sexual Health Clinic Attenders and People Living With HIV
Monkeypox · HIV Coinfection
Primary: Severe Mpox Lesions — 6; 2 participants — p=0.097
Phase 3 N=449 A Trial to Assess the Safety, Tolerability, and Pharmacokinetics of the Anti-Orthopoxvirus Compound Tecovirimat
Smallpox
Primary: To Determine the Number of Participants With Adverse Events — 134; 30 Participants
Phase 2 N=115 VSV-ZEBOV Geneva Vaccine Trial
Ebolavirus Disease
Primary: Titers of ZEBOV-specific IgG Antibodies — 1227; 25; 344.5 ELISA units per ml
Phase 1 N=39 Safety and Immunogenicity of Prime-Boost Vesicular Stomatitis Virus (VSV) Ebola Vaccine in Healthy Adults (V920-002)
Ebola Viruses
Primary: Percentage of Participants With 1 or More Unsolicited AE : Vaccination 1 — 60.0; 70.0; 50.0; 44.4 Percentage of participants
Phase 1 N=12 Phase I Trial of an Investigational Small Pox Medication
Orthopoxviral Disease · Smallpox · Monkey Pox
Primary: Pharmacokinetic Parameters for a Single Dose of ST-246 Form I vs. Form V: t½ — 27.446; 28.180 hours — p=0.4591
Phase 2 N=34 Study of a Live Attenuated Chikungunya Vaccine in a Previously Epidemic Area
Chikungunya
Primary: Number of Participants With AEs and Abnormal Lab Values, Vital Signs, and PE Findings — 11; 13; 4; 4 subjects
Phase 3 N=36 Detection and Characterisation of Varicella Zoster Virus From Dermal Lesions of Chickenpox-infected Patients
Varicella
Primary: Viral Load: Number of Varicella Zoster Virus (VZV) Deoxyribonucleic Acid (DNA) Copies Per Clinical Sample — 6.49; 6.46; 6.07; 6.02 VZV genome copies per sample
Phase 3 N=5,803 Evaluate Vaccine Against Chickenpox and a Combined Vaccine Against 4 Viral Childhood Diseases: Measles, Mumps, Rubella and Chickenpox
Varicella · Chickenpox Vaccines
Primary: Phase A: Number of Subjects With Confirmed Varicella Case — 37; 243; 201 Participants — p=<0.0001
Phase 2 N=357 Dose Study of ACAM2000 Smallpox Vaccine in Previously Vaccinated Adults
Smallpox
Primary: The Neutralizing Antibody Response Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine — 77; 112; 76; 91 PRNT50 Titers
Phase 2 N=745 A Randomized, Double-blind, Placebo-controlled Study on Immunogenicity and Safety of MVA-BN (IMVAMUNE™) Smallpox Vaccine in Healthy Subjects
Smallpox
Primary: Percentage of Participants With Seroconversion by ELISA — 98.9; 82.2; 3.4; 95.5 percentage of subjects
Phase 2 N=87 Randomized, Open-label Phase II Trial to Assess the Safety and Immunogenicity of MVA-BN Smallpox Vaccine in Immunocompromised Subjects With HIV Infection
Smallpox
Primary: Number of Participants With SAEs — 0; 0; 2; 0 Participants
Phase 3 N=1,129 Freeze-Dried MVA-BN® Lot Consistency Smallpox Trial
Smallpox
Primary: Vaccinia-Specific Neutralizing Antibodies Measured by Plaque Reduction Neutralization Test (PRNT) — 252.7; 269.9; 242.0 Titer
Phase 3 N=440 A Non-inferiority Trial to Compare MVA-BN® Smallpox Vaccine to ACAM2000®
18-42 Year Old Healthy Vaccinia-naïve Subjects
Primary: Plaque Reduction Neutralization Test (PRNT) Geometric Mean Titer (GMT) at the Peak Visits — 153.5; 79.3 Titer