Tag Archives: biologics

Clinical Trial of Chikungunya Vaccine

Safeguarding the health of clinical trial participants and the progression of trial results demands strict adherence to protocols.  Sentry BioPharma Services specializes in vaccine drug product storage, labeling, kitting and effective distribution for clinical trials worldwide.   Please see the following article concerning the National Institute of Health’s (NIH) phase 2 clinical trial of Chikungunya Vaccine which is now open and seeking patients.

NIH-Sponsored Clinical Trial of Chikungunya Vaccine Opens

This digitally-colorized transmission electron micrograph (TEM) depicts numerous chikungunya virus particles, which are composed of a central dense core that is surrounded by a viral envelope.
Credit: CDC
Clinical Trial of Chikungunya Vaccine

An experimental vaccine to protect against the mosquito-borne illness chikungunya is being tested in a Phase 2 trial sponsored by the National Institutes of Health. Results from an initial trial of the vaccine, which was developed by scientists at the NIH National Institute of Allergy and Infectious Diseases (NIAID), were reported in 2014. In that study, all 25 vaccine recipients developed robust immune responses and no safety concerns were noted. The new trial is designed to enroll 400 healthy adult volunteers aged 18 to 60 years old at six sites in the Caribbean. It will continue to gather data on the candidate vaccine’s safety and ability to elicit immune responses, including antibodies.
The hallmark symptoms of chikungunya are severe joint pain accompanied by fever and headache. The pain typically eases after about a week but can persist for months or years in some cases. There are no specific treatments for chikungunya infection and no vaccine to prevent it.
Since its appearance in the Western Hemisphere in late 2013, cases of chikungunya have skyrocketed. So far in 2015, more than 621,000 suspected and confirmed cases have been reported throughout the Americas.
“The recent re-emergence of chikungunya virus in this hemisphere has rapidly become a significant health burden,” said NIAID Director Anthony S. Fauci, M.D.  “Our chikungunya vaccine development efforts are part of a broader research effort to prevent, diagnose, treat and ultimately control this painful illness, which can strike anyone unlucky enough to be bitten by an infected mosquito.”
The experimental vaccine, developed by investigators at NIAID’s Vaccine Research Center, uses virus-like particles (VLPs) instead of either inactivated or weakened whole virus. VLP vaccines can stimulate immune responses comparable to those resulting from naturally acquired immunity following infection and, because virus is not needed to produce VLP vaccines, they do not need to be prepared in high-level biocontainment facilities.
Eligible volunteers will be randomly assigned to enroll into one of two groups of 200 people each. Study participants will receive either two doses of the candidate vaccine spaced 28 days apart or two doses of an inactive placebo. Blood samples will be drawn at multiple time points following the injections to assess whether the candidate vaccine prompted the production of antibodies to chikungunya virus.

Additional details about the trial can be found at ClinicalTrials.gov  using the identifier NCT02562482.

References:

L-J Chang et al. Chikungunya virus-like particle vaccine elicits neutralizing antibodies in healthy adults in a phase I dose escalation clinical trial. The Lancet DOI: 10.1016/S0140-6736(14)61185-5 (2014).

NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.

About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

Strict adherence to clinical material management protocols, in combination with proven GMP storage, secondary packaging, distribution, and shipping expertise allow Sentry to provide a variety of flexible services to our clinical trial outsourcing clients.

For more information about how Sentry can integrate your requirements into a scalable, secure, value-added clinical trial logistics solution, contact Sentry via email or by phone at 1-866-757-7400.

HPV (Human Papillomavirus) Vaccine – Gardasil®-9: What You Need to Know

Secure vaccine storage and distribution services protect your inventory throughout the supply chain. Sentry BioPharma Services ensures proper vaccine storage, rotation, accurate tracking and proper distribution of vaccines for routine fulfillment or pandemic response. Standard operating procedures (SOPs) and validated cold chain storage environments minimize time-out-of-refrigeration (TOR) risks, helping to reduce or eliminate waste attributable to inadequate storage methods.  Sentry provides the following vaccine information statement updated recently by the Centers For Disease Control and Prevention (CDC) concerning the human papillomavirus.

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HPV (Human Papillomavirus) Vaccine – Gardasil®-9: What You Need to Know

1. Why get vaccinated?

Gardasil-9 prevents human papillomavirus (HPV) types that cause many cancers, including:

  • cervical cancer in females,
  • vaginal and vulvar cancers in females,
  • anal cancer in females and males,
  • throat cancer in females and males, and
  • penile cancer in males.

In addition, Gardasil-9 prevents HPV types that cause genital warts in both females and males.

In the U.S., about 12,000 women get cervical cancer every year, and about 4,000 women die from it. Gardasil-9 can prevent most of these cases of cervical cancer.

Vaccination is not a substitute for cervical cancer screening. This vaccine does not protect against all HPV types that can cause cervical cancer.  Women should still get regular Pap tests.

HPV infection usually comes from sexual contact, and most people will become infected at some point in their life. About 14 million Americans, including teens, get infected every year.  Most infections will go away and not cause serious problems. But thousands of women and men get cancer and diseases from HPV.

2. HPV vaccine

Gardasil-9 is an FDA-approved HPV vaccine. It is recommended for both males and females. It is routinely given at 11 or 12 years of age, but it may be given beginning at age 9 years through age 26 years.

Three doses of Gardasil-9 are recommended with the second dose given 1-2 months after the first dose and the third dose given 6 months after the first dose.

3. Some people should not get this vaccine:

  • Anyone who has had a severe, life-threatening allergic reaction to a dose of HPV vaccine should not get another dose.
  • Anyone who has a severe (life threatening) allergy to any component of HPV vaccine should not get the vaccine.
  • Tell your doctor if you have any severe allergies that you know of, including a severe allergy to yeast.
  • HPV vaccine is not recommended for pregnant women. If you learn that you were pregnant when you were vaccinated, there is no reason to expect any problems for you or your baby. Any woman who learns she was pregnant when she got Gardasil-9 vaccine is encouraged to contact the manufacturer’s registry for HPV vaccination during pregnancy at 1-800-986-8999. Women who are breastfeeding may be vaccinated.
  • If you have a mild illness, such as a cold, you can probably get the vaccine today. If you are moderately or severely ill, you should probably wait until you recover. Your doctor can advise you.

4. Risks of a vaccine reaction

With any medicine, including vaccines, there is a chance of side effects. These are usually mild and go away on their own, but serious reactions are also possible.

Most people who get HPV vaccine do not have any serious problems with it.

Mild or moderate problems following Gardasil-9:

  • Reactions in the arm where the shot was given:
  • Soreness (about 9 people in 10)
  • Redness or swelling (about 1 person in 3)
  • Fever:
  • Mild (100°F) (about 1 person in 10)
  • Moderate (102°F) (about 1 person in 65)
  • Other problems:
  • Headache (about 1 person in 3)

Problems that could happen after any injected vaccine:

  • People sometimes faint after a medical procedure, including vaccination. Sitting or lying down for about 15 minutes can help prevent fainting, and injuries caused by a fall. Tell your doctor if you feel dizzy, or have vision changes or ringing in the ears.
  • Some people get severe pain in the shoulder and have difficulty moving the arm where a shot was given. This happens very rarely.
  • Any medication can cause a severe allergic reaction. Such reactions from a vaccine are very rare, estimated at about 1 in a million doses, and would happen within a few minutes to a few hours after the vaccination.

As with any medicine, there is a very remote chance of a vaccine causing a serious injury or death.

The safety of vaccines is always being monitored.  For more information, visit: www.cdc.gov/vaccinesafety/.

5. What if there is a serious reaction?

What should I look for?

Look for anything that concerns you, such as signs of a severe allergic reaction, very high fever, or unusual behavior.

Signs of a severe allergic reaction can include hives, swelling of the face and throat, difficulty breathing, a fast heartbeat, dizziness, and weakness. These would usually start a few minutes to a few hours after the vaccination.

What should I do?

If you think it is a severe allergic reaction or other emergency that can’t wait, call 9-1-1 or get to the nearest hospital. Otherwise, call your doctor.

Afterward, the reaction should be reported to the “Vaccine Adverse Event Reporting System” (VAERS). Your doctor should file this report, or you can do it yourself through the VAERS web site at www.vaers.hhs.gov, or by calling 1-800-822-7967.  VAERS does not give medical advice.

6. The National Vaccine Injury Compensation Program

The National Vaccine Injury Compensation Program (VICP) is a federal program that was created to compensate people who may have been injured by certain vaccines.

Persons who believe they may have been injured by a vaccine can learn about the program and about filing a claim by calling 1-800-338-2382 or visiting the VICP website at www.hrsa.gov/vaccinecompensation. There is a time limit to file a claim for compensation.

7. How can I learn more?

  • Ask your health care provider. He or she can give you the vaccine package insert or suggest other sources of information.
  • Call your local or state health department.
  • Contact the Centers for Disease Control and Prevention (CDC):
  • Call 1-800-232-4636 (1-800-CDC-INFO) or

Visit CDC’s website at www.cdc.gov/hpv 

For more information about how Sentry’s proven vaccine management system can protect your vaccine throughout the global supply chain, contact Sentry via email or by phone at 1-866-757-7400.

 

Global Drug Supply Disruptions

Sentry BioPharma Services is a leading service provider for pharmaceutical companies needing to diversify their critical drug safety stocks, thereby reducing their risk of drug shortages brought on by unforeseen calamities.

“In the aftermath of the devastating earthquake and tsunami on March 11, 2011, our company entered into numerous agreements with Japanese pharmaceutical manufacturers,” stated Tim Mitchell, Sentry’s President.  “In support of their risk mitigation programs, companies divided their critical drug supplies between their facilities and Sentry’s central Indiana U.S. GMP facility”.

Global Drug Supply Disruptions

April 2016 Earthquake area: Traced from a report of The Geospatial Information Authority of Japan. 

The article below is provided for information purposes. 

Japan Today AFP

Plants shut down after quake, fueling economic fears

Apr. 16, 2016 – 06:10AM JST

TOKYO —

Some of Japan’s biggest firms including Sony and Toyota shut down operations in southern Japan Friday after the region’s deadly earthquake…

Read more…

Sentry provides GMP validated temperature product management and global distribution of high value drug products, from API to finished vaccines.  Sentry’s validated temperatures range from +15°C to -90°C with multiple temperature set points in between.

To learn more about how Sentry can help your company lower product loss risks contact Sentry via email or by phone at 1-866-757-7400.

Proper Blood Storage and Distribution Helps the Shortage

Did you know that blood cannot be manufactured?  In this age of advanced pharmaceutical and biological product development, that comes as quite a surprise to many; but it is true.  The American Red Cross faces blood shortages.

According to the American Red Cross website:

  • One pint of blood can save three lives.
  • Every two seconds someone in the U.S. needs blood.
  • A single car accident victim can require as many as 100 pints of blood.
  • Approximately 36,000 units of red blood cells are needed every day in the U.S.
  • Nearly 7,000 units of platelets and 10,000 units of plasma are needed daily in the U.S.
  • Nearly 21 million blood components are transfused each year in the U.S.
  • The average red blood cell (RBC) transfusion is approximately three pints.
  • More than 1.68 million people are expected to be diagnosed with cancer in 2016. Many of them will need blood, sometimes daily, during their chemotherapy treatment.

Ms. Jennifer Marcum, Sentry BioPharma Services’ CEO, acknowledges the need by stating, ” Blood can only come from generous donors.  There are approximately 7 million blood donors in the U.S.  A healthy donor may donate red blood cells every 56 days.  Most people don’t think they will need blood, but there is a tremendous continual need.”

Ms. Marcum continues, “Proper blood storage and temperature-sensitive product shipping is of great importance to the blood supply chain.  After donated whole blood passes processing and testing, red blood cells are stored in refrigerators at 6°C for up to 42 days.  Blood used in an emergency must be readily available on the shelves before the event occurs.  Effective cold chain management protects the biological product’s integrity.”

Sentry BioPharma Services offer biological product storage to pharmaceutical companies, hospitals and organizations with need for validated refrigerated (+2°C to +8°C) storage and temperature-sensitive product shipping services.  For more information about how Sentry’s GMP warehouse can help protect the integrity of the blood supply chain and biological products in general, contact Sentry via email or by phone at 1-866-757-7400.

Red Cross Blood Drive