Diphtheria

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17Active trials35Specialists8Treatment centers

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UniteRare data is sourced from FDA.gov, ClinicalTrials.gov, Orphanet, OMIM, and NORD.
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Overview

Diphtheria is an acute infectious disease caused by toxin-producing strains of the bacterium Corynebacterium diphtheriae. It is not a genetic disorder but rather an acquired bacterial infection that primarily affects the mucous membranes of the upper respiratory tract (pharyngeal and laryngeal diphtheria) and, less commonly, the skin (cutaneous diphtheria). The hallmark of respiratory diphtheria is the formation of a tough, grayish-white pseudomembrane in the throat and tonsils, which can obstruct the airway and cause difficulty breathing, a barking cough, hoarseness, and stridor. Systemic absorption of the diphtheria toxin can lead to serious complications affecting the heart (myocarditis, cardiac arrhythmias, heart failure), the nervous system (cranial and peripheral neuropathies, including palatal paralysis and limb weakness), and the kidneys (tubular necrosis). Other symptoms include sore throat, low-grade fever, cervical lymphadenopathy, and neck swelling sometimes described as a 'bull neck' appearance. Diphtheria was once a leading cause of childhood mortality but has become rare in developed countries due to widespread vaccination with diphtheria toxoid (included in DTaP/Tdap vaccines). However, it remains endemic in parts of Africa, South and Southeast Asia, and other regions with low vaccination coverage. Treatment involves prompt administration of diphtheria antitoxin (DAT) to neutralize circulating toxin, along with antibiotic therapy (typically erythromycin or penicillin) to eradicate the organism and prevent transmission. Supportive care, including airway management and cardiac monitoring, is essential. The case fatality rate remains approximately 5–10% even with treatment, and is higher in young children and the elderly. Prevention through routine immunization remains the most effective strategy against this disease.

Age of Onset

Variable

Can begin at different ages, from infancy through adulthood

Orphanet ↗NORD ↗

FDA & Trial Timeline

10 events
Apr 2026A Phase I Clinical Trial of Absorbed Acellular Pertussis (Two-Component) Diphtheria-Tetanus Combined Vaccine (For Adults and Adolescents)

Changchun BCHT Biotechnology Co. — PHASE1

TrialNOT YET RECRUITING
Mar 2026Phase I/II Clinical Trial of Diphtheria-Tetanus-Pertussis (Reduced Dose) Vaccine

Institute of Medical Biology, Chinese Academy of Medical Sciences — PHASE1, PHASE2

TrialNOT YET RECRUITING
Dec 2025Clinical Trial of the Adsorbed Acellular Pertussis (Tricomponent) DTaP-Haemophilus Influenzae Type b (Conjugate)-ACYW135 Group Meningococcal (Conjugate) Combined Vaccine

CanSino Biologics Inc. — PHASE1

TrialRECRUITING
Oct 2025Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy

Canadian Immunization Research Network — PHASE4

TrialRECRUITING
Jun 2025Adsorption of Cell-free Diphtheria and Tetanus (Three-component) Combined With Vaccine Phase III Clinical Trial

Changchun BCHT Biotechnology Co. — PHASE3

TrialRECRUITING
Jun 2025A Phase I/II Study to Evaluate the Safety and Immunogenicity of GC3111B in Healthy Adults

GC Biopharma Corp — PHASE1, PHASE2

TrialRECRUITING
Jun 2025Enhancing Maternal Vaccine Knowledge and Uptake: the InTroDuce-Programme Trial

Universiti Putra Malaysia — NA

TrialNOT YET RECRUITING
May 2025A Phase II/III Study to Evaluate the Immunogenicity, Safety and Lot-to-lot Consistency of LBVD, a Fully Liquid Hexavalent Diphtheria-tetanus-whole Cell Pertussis-hepatitis B-poliovirus-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, in Healthy Infants as Primary Series

LG Chem — PHASE2, PHASE3

TrialRECRUITING
May 2025Study of Concomitant Administration of the sIPV and DTaP or MMR

Institute of Medical Biology, Chinese Academy of Medical Sciences — PHASE4

TrialNOT YET RECRUITING
May 2025BCG Revaccination With the Third Dose of Diphtheria-tetanus-pertussis Vaccine and Infant Mortality in Africa

Bandim Health Project — PHASE4

TrialENROLLING BY INVITATION

Data sourced from FDA regulatory filings and ClinicalTrials.gov. Updated periodically.

Treatments

No FDA-approved treatments are currently listed for Diphtheria.

17 clinical trialsare actively recruiting — trials can provide access to cutting-edge therapies.

View clinical trials →

Clinical Trials

17 recruitingView all trials with filters →
Phase 35 trials
A Clinical Trial of Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed(DTcP)
Phase 3
Active
· Sites: Xuchang, Henan
A Phase 3 Study of BIBP Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed
Phase 3
Active
PI: Lili Huang (Henan Province Center for Disease Control and Prev) · Sites: Anyang, Henan; Jiaozuo, Henan +2 more
Inter-lot Consistency Clinical Trial of Adsorbed Cell-free DTP (Three-component) Combined Vaccine
Phase 3
Active
PI: Yanxia Wang (Henan Center for Disease Control and Prevention) · Sites: Xuchang, Henan
Adsorption of Cell-free Diphtheria and Tetanus (Three-component) Combined With Vaccine Phase III Clinical Trial
Phase 3
Actively Recruiting
· Sites: Wenshan Zhuang and Miao Autonomous Prefecture, Yunnan
Immunogenicity and Safety of Diphtheria, Tetanus, Pertussis (DTaP) Vaccine in 3-month-old Infants
Phase 3
Actively Recruiting
PI: Lin Du (Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd) · Sites: Nanning, Guangxi
Phase 43 trials
BCG Revaccination With the Third Dose of Diphtheria-tetanus-pertussis Vaccine and Infant Mortality in Africa
Phase 4
Enrolling by Invitation
PI: Christine Stabell Benn, MD, PhD, DMSc (Bandim Health Project and Danish Institute for Adv) · Sites: Bissau
Assessing Interventions to Increase Tdap Acceptance for Non-birthing Partners in Pregnancy
Phase 4
Actively Recruiting
PI: Laurie Griffin, MD/PhD (Women and Infants Hospital) · Sites: Providence, Rhode Island · Age: 1950 yrs
Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy
Phase 4
Actively Recruiting
PI: Bahaa Abu-Raya, M.D., PhD (Canadian Center for Vaccinology, Dalhousie Univers) · Sites: Vancouver, British Columbia; Halifax, Nova Scotia +2 more · Age: 1849 yrs
Phase 14 trials
Phase I Clinical Trial of Diphtheria-Tetanus-acellular Pertussis Component Combined Vaccine
Phase 1
Actively Recruiting
· Sites: Dazhou, Sichuan; Yibin, Sichuan +1 more · Age: 06 yrs
A Clinical Trial of Adsorbed Cell-free DPT Vaccine (5-component) (for People Aged 6 Years and Above)
Phase 1
Active
· Sites: Xi'an, Shaanxi · Age: 699 yrs
Tagraxofusp-erzs, an IL-3 Diphtheria Fusion Protein, in Combination With Gemtuzumab Ozogamicin in Patients With Relapsed/Refractory AML
Phase 1
Active
PI: Alexander Ambinder, MD (SKCCC Johns Hopkins Medical Institution) · Sites: Baltimore, Maryland · Age: 1299 yrs
Clinical Trial of the Adsorbed Acellular Pertussis (Tricomponent) DTaP-Haemophilus Influenzae Type b (Conjugate)-ACYW135 Group Meningococcal (Conjugate) Combined Vaccine
Phase 1
Actively Recruiting
PI: Yanxia Wang (Henan Center for Disease Control and Prevention) · Sites: Shangqiu, Henan · Age: 06 yrs
N/A1 trial
Safety and Immunogenicity of DTaP-IPV/Hib Pentavalent Vaccine in Chinese 2-month-old Infants
N/A
Actively Recruiting
PI: jingxin42102209@126.com Li (Jingsu Provincial Centre of Disease Control and Pr) · Sites: Nanjing, Jiangsu
Other1 trial
Safety of Tetanus, Diphtheria, Acellular Pertussis With 5 Acellular Pertussis Components (Tdap5) Vaccination During Pregnancy
Active
PI: Clinical Sciences & Operations (Sanofi) · Sites: Chilly-Mazarin · Age: 1549 yrs

Specialists

Showing 25 of 35View all specialists →
YB
Yuemei Hu, Bachelor
Specialist
PI on 5 active trials
GM
General Manager
Specialist
PI on 14 active trials6 Diphtheria publications
SM
Sean O'Leary, MD, MPH
Specialist
PI on 2 active trials
MC
Maria RZ Capeding
Specialist
PI on 2 active trials
AF
Anne Fiquet
Specialist
PI on 1 active trial
RP
Rigmor Thorstensson, Assoc. Prof.
Specialist
PI on 1 active trial
TH
Tran Ngoc Huu
Specialist
PI on 1 active trial
HM
Hung Chiun Lau, Dr Fam Med
Specialist
PI on 1 active trial
AT
Adam Thaler
BERKELEY HEIGHTS, NJ
Specialist
PI on 1 active trial
BA
Bahaa Abu-Raya
Specialist
PI on 1 active trial
WK
WJ Kim
Specialist
PI on 1 active trial
PD
Pompa Debroy
Specialist
PI on 1 active trial
EF
Eddy Fadlyana
Specialist
PI on 1 active trial
FD
Fabien DUTASTA
Specialist
PI on 1 active trial
WY
Wang Yanxia
Specialist
PI on 1 active trial
JS
John Z Sullivan-Bólyai
Specialist
PI on 1 active trial
JK
Jong Hyun Kim
Specialist
PI on 1 active trial
AB
Aleksandra Banaszkiewicz
Specialist
PI on 2 active trials
LH
Lili Huang
Specialist
PI on 1 active trial
HH
Hanqing He
Specialist
PI on 1 active trial
EC
Elizabeth Coates
Specialist
PI on 1 active trial
EA
Edison Alberto
Specialist
PI on 1 active trial
SO
Shintaro Okada
Specialist
PI on 1 active trial
LG
Leif Gothefors
Specialist
PI on 1 active trial
BE
Byeonguk Eun
Specialist
PI on 1 active trial

Treatment Centers

8 centers
🏥 NORD

Baylor College of Medicine Rare Disease Center

Baylor College of Medicine

📍 Houston, TX

🏥 NORD

Stanford Medicine Rare Disease Center

Stanford Medicine

📍 Stanford, CA

🔬 UDN

NIH Clinical Center Undiagnosed Diseases Program

National Institutes of Health

📍 Bethesda, MD

🔬 UDN

UCLA UDN Clinical Site

UCLA Health

📍 Los Angeles, CA

🔬 UDN

Baylor College of Medicine UDN Clinical Site

Baylor College of Medicine

📍 Houston, TX

🔬 UDN

Harvard/MGH UDN Clinical Site

Massachusetts General Hospital

📍 Boston, MA

🏥 NORD

Mayo Clinic Center for Individualized Medicine

Mayo Clinic

📍 Rochester, MN

👤 Mayo Clinic Center for Individualized Medicine

🏥 NORD

UCLA Rare Disease Day Program

UCLA Health

📍 Los Angeles, CA

Travel Grants

No travel grants are currently matched to Diphtheria.

Search all travel grants →NORD Financial Assistance ↗

Community

Open DiphtheriaForum →

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Latest news about Diphtheria

Disease timeline:

New recruiting trial: Prospective Biological Study to Evaluate the Persistence of COVID-19 Vaccine and Other Vaccines'-Induced Immune Responses in Follicular Lymphoma Patients Undergoing Frontline Induction Immuno-chemotherapy and Anti-CD20 Maintenance

A new clinical trial is recruiting patients for Diphtheria

New recruiting trial: A Phase II/III Study to Evaluate the Immunogenicity, Safety and Lot-to-lot Consistency of LBVD, a Fully Liquid Hexavalent Diphtheria-tetanus-whole Cell Pertussis-hepatitis B-poliovirus-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, in Healthy Infants as Primary Series

A new clinical trial is recruiting patients for Diphtheria

New recruiting trial: Immunogenicity and Safety of Diphtheria, Tetanus, Pertussis (DTaP) Vaccine in 3-month-old Infants

A new clinical trial is recruiting patients for Diphtheria

New recruiting trial: Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy

A new clinical trial is recruiting patients for Diphtheria

New recruiting trial: Assessing Interventions to Increase Tdap Acceptance for Non-birthing Partners in Pregnancy

A new clinical trial is recruiting patients for Diphtheria

New recruiting trial: Phase I Clinical Trial of Diphtheria-Tetanus-acellular Pertussis Component Combined Vaccine

A new clinical trial is recruiting patients for Diphtheria

New recruiting trial: Clinical Trial of the Adsorbed Acellular Pertussis (Tricomponent) DTaP-Haemophilus Influenzae Type b (Conjugate)-ACYW135 Group Meningococcal (Conjugate) Combined Vaccine

A new clinical trial is recruiting patients for Diphtheria

New recruiting trial: A Phase I/II Study to Evaluate the Safety and Immunogenicity of GC3111B in Healthy Adults

A new clinical trial is recruiting patients for Diphtheria

New recruiting trial: Adsorption of Cell-free Diphtheria and Tetanus (Three-component) Combined With Vaccine Phase III Clinical Trial

A new clinical trial is recruiting patients for Diphtheria

New recruiting trial: Safety and Immunogenicity of DTaP-IPV/Hib Pentavalent Vaccine in Chinese 2-month-old Infants

A new clinical trial is recruiting patients for Diphtheria

Caregiver Resources

NORD Caregiver Resources

Support, advocacy, and financial assistance for caregivers of rare disease patients.

Mental Health Support

Rare disease caregiving can be isolating. Connect with counseling and peer support.

Family & Caregiver Grants

Financial assistance programs specifically for caregivers of rare disease patients.

Social Security Disability

Learn how rare disease patients may qualify for SSDI/SSI benefits.

Common questions about Diphtheria

What is Diphtheria?

Diphtheria is an acute infectious disease caused by toxin-producing strains of the bacterium Corynebacterium diphtheriae. It is not a genetic disorder but rather an acquired bacterial infection that primarily affects the mucous membranes of the upper respiratory tract (pharyngeal and laryngeal diphtheria) and, less commonly, the skin (cutaneous diphtheria). The hallmark of respiratory diphtheria is the formation of a tough, grayish-white pseudomembrane in the throat and tonsils, which can obstruct the airway and cause difficulty breathing, a barking cough, hoarseness, and stridor. Systemic abs

Are there clinical trials for Diphtheria?

Yes — 17 recruiting clinical trials are currently listed for Diphtheria on UniteRare. See the clinical trials section on this page for phase, sponsor, and site details sourced from ClinicalTrials.gov.

Which specialists treat Diphtheria?

25 specialists and care centers treating Diphtheria are listed on UniteRare, sourced from ClinicalTrials.gov principal investigators, published research, and the NPPES NPI registry.